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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-005011-14 | EudraCT Number |
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| Name | Class |
|---|---|
| Pharmaceutical Product Development, (PPD) LLC | INDUSTRY |
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This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Flurpiridaz PET MPI (following off-study SPECT MPI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET MPI | Drug | Flurpiridaz (18F) Injection. All participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein: 1 at rest and 1 during stress. The dosages of Flurpiridaz (18F) Injection administered at rest and during stress conditions did not exceed a total of 14 mCi (520 MBq) for an individual participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of Flurpiridaz (18F) Injection Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) in the Detection of Significant Coronary Artery Disease (CAD) as Defined by Cardiac Catheterization | Sensitivity was defined as true positives (TP)/(TP+false negatives [FN]). TP was participants with abnormal PET MPI and disease positive by truth standard and FN was participants with normal PET MPI and disease positive by truth standard. Specificity defined as true negatives (TN)/(TN+ false positives [FP]). TN was participants with normal PET MPI and disease negative by truth standard and FP was participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of >=50 percent (%) in >=1 coronary artery or major branch of a coronary artery as determined by quantitative coronary angiography (QCA) analysis. Participants were considered to have CAD if QCA revealed >=50% stenosis of >=1 major coronary artery or major branch. Sensitivity and specificity were calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. | Up to 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for All Participants When the Diagnosis of CAD by ICA Was the Standard of Truth | Sensitivity:TP/(TP+FN). TP:participants with abnormal PET MPI and disease positive by truth standard and FN:participants with normal PET MPI and disease positive by truth standard. Specificity:TN/(TN+ FP). TN:participants with normal PET MPI and disease negative by truth standard and FP:participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of >=50% in >=1 coronary artery or major branch of coronary artery as determined by QCA analysis. Participants considered to have CAD if QCA revealed >=50% stenosis of >=1 major coronary artery or major branch. Sensitivity, specificity was calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. Sensitivity, specificity of Flurpiridaz (18F) PET MPI compared to SPECT MPI with QCA as standard of truth at >=50% stenosis threshold for all participants was reported by reader and majority rule. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Participants who were pregnant, may possibly be pregnant, or wish (including their partners) to became pregnant during the study period, or were lactating.
Participants who were unable to undergo all of the imaging procedures.
Participants who had an established diagnosis of CAD as confirmed by any of the following:
Participants incapable of undergoing either exercise or pharmacological cardiac stress testing.
Participants who had a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the participant during cardiac stress testing.
Documented history of heart failure and/or cardiomyopathy and/or prior LV ejection fraction (LVEF) <50%).
Participants scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ICA.
Participants undergoing evaluation for heart transplantation or with history of heart transplantation.
Participants enrolled in another clinical study within the 30 days prior to being enrolled in this study or scheduled to participate in another clinical study during the 7-day follow-up period of this study.
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| Name | Affiliation | Role |
|---|---|---|
| Francois Tranquart, M.D., Ph.D. | General Electric Healthcare Life Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular Biology and Hypertension Program, University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42128226 | Derived | Patel KK, Maddahi J, Agostini D, Bax JJ, Beanlands RSB, Berman D, Dorbala S, Heller GV, Knuuti JM, Pelletier-Galarneau M, Tamaki N, Thompson D, Somer EJ, Udelson JE, Bateman TM. Improved assessment of coronary artery disease in obese Patients with flurpiridaz-18F positron emission tomography myocardial perfusion imaging: A prespecified subgroup analysis of the AURORA phase 3 study. J Nucl Cardiol. 2026 May 12:102741. doi: 10.1016/j.nuclcard.2026.102741. Online ahead of print. | |
| 37821170 |
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A total 730 participants signed informed consent and were enrolled, of these, 604 participants received greater than or equal to (>=) 1 dose of Flurpiridaz (18F) Injection in this study.
This study was conducted at 48 centers in Finland, France, Germany, Netherlands, United States and Canada from 05 June 2018 to 05 May 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Flurpiridaz (18F): All Participants | Participants received 2 intravenous (IV) boluses of Flurpiridaz (18F) Injection in a large peripheral vein: 1 at rest then 1 during stress on the same day within 60 days prior to the invasive coronary angiography (ICA). Flurpiridaz (18F) Injection administered at rest and during stress conditions were not to exceed a total of 14 millicurie (mCi) (520 megabecquerel [MBq]) for an individual participant. Flurpiridaz was administered on Study Day 1. Single photon emission computed tomography (SPECT) agents 99mTc-based myocardial tracers, example [99mTc]tetrofosmin or [99mTc]sestamibi were administered as per American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location. For each participant, the same stress type (pharmacologic or exercise) was used for the SPECT and Flurpiridaz (18F) Injection positron emission tomography (PET) myocardial perfusion imaging (MPI). Also, if pharmacological stress was used, the same agent and the same dose of pharmacological stress agent was used for both types of imaging for the same participant. Pharmacological stress agents were administered according to the respective Package Insert (as applicable) or American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 22, 2021 | Jun 5, 2023 |
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|
| SPECT MPI | Drug | SPECT imaging was used 99mTc-based myocardial tracers. SPECT agents utilised for the purposes of this clinical study was administered as per American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards, where applicable. All participants undergone SPECT MPI. |
|
| Pharmacological stress agents | Drug | Pharmacologic stress agents were restricted to the following 3 agents, as permitted by local marketing authorisations and availability: adenosine, dipyridamole, and regadenoson. Administration was through an IV line. |
|
| Up to 60 days |
| Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Female Participants When the Diagnosis of CAD by ICA Was the Standard of Truth | Sensitivity:TP/(TP+FN). TP:participants with abnormal PET MPI and disease positive by truth standard and FN:participants with normal PET MPI and disease positive by truth standard. Specificity:TN/(TN+ FP). TN:participants with normal PET MPI and disease negative by truth standard and FP:participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of >=50% in >=1 coronary artery or major branch of a coronary artery as determined by QCA analysis. Participants considered to have CAD if QCA revealed >=50% stenosis of >=1 major coronary artery or major branch. Sensitivity, specificity calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. Sensitivity, specificity of Flurpiridaz (18F) PET MPI compared to SPECT MPI with QCA as standard of truth at >=50% stenosis threshold for female participants was reported by reader and majority rule. | Up to 60 days |
| Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Participants With Body-mass Index (BMI) >=30 Kilograms Per Square Meter (kg/m^2) When the Diagnosis of CAD by ICA Was the Standard of Truth | Sensitivity:TP/(TP+FN). TP:participants with abnormal PET MPI and disease positive by truth standard and FN:participants with normal PET MPI and disease positive by truth standard. Specificity:TN/(TN+ FP). TN:participants with normal PET MPI and disease negative by truth standard and FP:participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of >=50% in >=1 coronary artery or major branch of coronary artery determined by QCA analysis. Participants considered to have CAD if QCA revealed >=50% stenosis of >=1 major coronary artery or major branch. Sensitivity, specificity calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. Sensitivity, specificity of Flurpiridaz (18F) PET MPI compared to SPECT MPI with QCA as standard of truth at >=50% stenosis threshold for participants(BMI>=30 kg/m^2) reported by reader and majority rule. | Up to 60 days |
| Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Diabetic Participants When the Diagnosis of CAD by ICA Was the Standard of Truth | Sensitivity:TP/(TP+FN). TP:participants with abnormal PET MPI and disease positive by truth standard and FN:participants with normal PET MPI and disease positive by truth standard. Specificity:TN/(TN+ FP). TN:participants with normal PET MPI and disease negative by truth standard and FP:participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of >=50% in >=1 coronary artery or major branch of coronary artery determined by QCA analysis. Participants considered to have CAD if QCA revealed >=50% stenosis of >=1 major coronary artery or major branch. Sensitivity and specificity calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. Sensitivity, specificity of Flurpiridaz (18F) PET MPI compared to SPECT MPI with QCA as standard of truth at >=50% stenosis threshold for diabetic participants was reported by reader and majority rule. | Up to 60 days |
| University of California- Los Angeles |
| Los Angeles |
| California |
| 90024 |
| United States |
| Keck Hospital of USC | Los Angeles | California | 90033 | United States |
| VA Greater Los Angeles Health Care System | Los Angeles | California | 90073 | United States |
| VA San Diego Health System | San Diego | California | 92161 | United States |
| UCSF | San Francisco | California | 94107 | United States |
| Tower Saint John's Imaging | Santa Monica | California | 90403 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| Cardiology Physicians PA/Red Clay Research LLC | Newark | Delaware | 19713 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Indago Research and Health Center | Hialeah | Florida | 33012 | United States |
| Optimus U Corp | Miami | Florida | 33125 | United States |
| Infinite Clinical Research | Miami | Florida | 33133-4214 | United States |
| Allied Biomedical Research Institute | Miami | Florida | 33155 | United States |
| Comprehensive Vascular Care PA | Miami | Florida | 33155 | United States |
| Amavita Clinical Research, LLC | North Miami Beach | Florida | 33169 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| University Of Iowa Hospitals And Clinics | Iowa City | Iowa | 52242 | United States |
| Midwest Heart and Vascular Specialists | Overland Park | Kansas | 66211 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| VA St. Louis Health Care System | St Louis | Missouri | 63106 | United States |
| St Louis University | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Columbia University Medical Center/New York Presbyterian Hospital - Milstein Hospital Building | New York | New York | 10032 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| OhioHealth Research Institute | Columbus | Ohio | 43214 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Berks Cardiologists, LTD | Wyomissing | Pennsylvania | 19610 | United States |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | United States |
| VA North Texas Health Care System - NAVREF - PPDS | Dallas | Texas | 75216 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| The Methodist Hospital Research Institute | Houston | Texas | 77030 | United States |
| Vital Heart & Vein | Humble | Texas | 77338 | United States |
| Memorial City and Katy Cardiology Associates | Katy | Texas | 77493 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Roanoke Heart Institute | Roanoke | Virginia | 24014 | United States |
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | Canada |
| Center Hospitalier Universitaire de Sherbrooke CHUS | Montreal | Quebec | J1H 5N4 | Canada |
| Turku University Hospital | Turku | FI-20520 | Finland |
| Hopital Cote de Nacre | Caen | 14033 | France |
| Groupe Hospitalier Bichat Claude Bernard | Paris | 75018 | France |
| Centre Cardiologique Du Nord | Saint-Denis | 93200 | France |
| Universitätsklinikum der RWTH Aachen | Aachen | 52074 | Germany |
| Universitätsklinikum Essen | Essen | 45147 | Germany |
| VU Medisch Centrum | Amsterdam | 1081 HV | Netherlands |
| Amphia Ziekenhuis - WCN - PPDS | Breda | 4818 CK | Netherlands |
| Catharina Hospital | Eindhoven | 5623 EJ | Netherlands |
| Zuyderland Medisch Centrum-WCN-PPDS | Heerlen | 6419 PC | Netherlands |
| Leids Universitair Medisch Centrum | Leiden | 2333ZA | Netherlands |
| Hopitaux Universitaires de Geneve | Geneva | 1205 | Switzerland |
| Universitatsspital Zurich | Zurich | 8091 | Switzerland |
| Derived |
| Maddahi J, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, Berman DS, Dorbala S, Garcia EV, Feldman J, Heller GV, Knuuti JM, Martinez-Clark P, Pelletier-Galarneau M, Shepple B, Tamaki N, Tranquart F, Udelson JE. Flurpiridaz F-18 PET Myocardial Perfusion Imaging in Patients With Suspected Coronary Artery Disease. J Am Coll Cardiol. 2023 Oct 17;82(16):1598-1610. doi: 10.1016/j.jacc.2023.08.016. |
| 33521873 | Derived | Bourque JM, Hanson CA, Agostini D, Bateman TM, Bax JJ, Beanlands RSB, Berman DS, Garcia EV, Heller GV, Knuuti J, Tamaki N, Udelson JE, Maddahi J. Assessing myocardial perfusion in suspected coronary artery disease: rationale and design of the second phase 3, open-label multi-center study of flurpiridaz (F-18) injection for positron emission tomography (PET) imaging. J Nucl Cardiol. 2021 Jun;28(3):1105-1116. doi: 10.1007/s12350-021-02527-8. Epub 2021 Jan 31. |
| Safety Population (Treated) |
|
| Modified Intent-to-Treat (MITT) Population |
|
| Secondary Modified Intent-to-Treat (SMITT) Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The enrolled population consisted of all participants who signed informed consent.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Flurpiridaz (18F): All Participants | Participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein: 1 at rest then 1 during stress on the same day within 60 days prior to the ICA. Flurpiridaz (18F) Injection administered at rest and during stress conditions were not to exceed a total of 14 mCi (520 MBq) for an individual participant. Flurpiridaz was administered on Study Day 1. SPECT agents 99mTc-based myocardial tracers, example [99mTc]tetrofosmin or [99mTc]sestamibi were administered as per American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location. For each participant, the same stress type (pharmacologic or exercise) was used for the SPECT and Flurpiridaz (18F) Injection PET MPI. Also, if pharmacological stress was used, the same agent and the same dose of pharmacological stress agent was used for both types of imaging for the same participant. Pharmacological stress agents were administered according to the respective Package Insert (as applicable) or American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity and Specificity of Flurpiridaz (18F) Injection Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) in the Detection of Significant Coronary Artery Disease (CAD) as Defined by Cardiac Catheterization | Sensitivity was defined as true positives (TP)/(TP+false negatives [FN]). TP was participants with abnormal PET MPI and disease positive by truth standard and FN was participants with normal PET MPI and disease positive by truth standard. Specificity defined as true negatives (TN)/(TN+ false positives [FP]). TN was participants with normal PET MPI and disease negative by truth standard and FP was participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of >=50 percent (%) in >=1 coronary artery or major branch of a coronary artery as determined by quantitative coronary angiography (QCA) analysis. Participants were considered to have CAD if QCA revealed >=50% stenosis of >=1 major coronary artery or major branch. Sensitivity and specificity were calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. | The MITT population included all participants who completed the rest and stress Flurpiridaz (18F) Injection PET MPI procedures and who had evaluable truth standard data. Here, "overall number of participants analyzed" signifies participants who were analyzed for a specific reader (combined sensitivity or specificity) and "number analyzed" signifies participants who were evaluable for specified categories. | Posted | Number | 95% Confidence Interval | percent | Up to 60 days |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for All Participants When the Diagnosis of CAD by ICA Was the Standard of Truth | Sensitivity:TP/(TP+FN). TP:participants with abnormal PET MPI and disease positive by truth standard and FN:participants with normal PET MPI and disease positive by truth standard. Specificity:TN/(TN+ FP). TN:participants with normal PET MPI and disease negative by truth standard and FP:participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of >=50% in >=1 coronary artery or major branch of coronary artery as determined by QCA analysis. Participants considered to have CAD if QCA revealed >=50% stenosis of >=1 major coronary artery or major branch. Sensitivity, specificity was calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. Sensitivity, specificity of Flurpiridaz (18F) PET MPI compared to SPECT MPI with QCA as standard of truth at >=50% stenosis threshold for all participants was reported by reader and majority rule. | The SMITT population included the participants who completed the rest and stress SPECT MPI (if the participant's SPECT MPI was "off-study," that SPECT MPI had to meet minimal quality standards, as specified by the imaging core lab). Here, "overall number of participants analyzed" signifies participants who were analyzed for a specific reader (combined sensitivity or specificity) and "number analyzed" signifies participants who were evaluable for specified categories. | Posted | Number | 95% Confidence Interval | percent | Up to 60 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Female Participants When the Diagnosis of CAD by ICA Was the Standard of Truth | Sensitivity:TP/(TP+FN). TP:participants with abnormal PET MPI and disease positive by truth standard and FN:participants with normal PET MPI and disease positive by truth standard. Specificity:TN/(TN+ FP). TN:participants with normal PET MPI and disease negative by truth standard and FP:participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of >=50% in >=1 coronary artery or major branch of a coronary artery as determined by QCA analysis. Participants considered to have CAD if QCA revealed >=50% stenosis of >=1 major coronary artery or major branch. Sensitivity, specificity calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. Sensitivity, specificity of Flurpiridaz (18F) PET MPI compared to SPECT MPI with QCA as standard of truth at >=50% stenosis threshold for female participants was reported by reader and majority rule. | The SMITT population included the participants who completed the rest and stress SPECT MPI (if the participant's SPECT MPI was "off-study," that SPECT MPI had to meet minimal quality standards, as specified by the imaging core lab). Here, "overall number of participants analyzed" signifies participants who were analyzed for a specific reader (combined sensitivity or specificity) and "number analyzed" signifies participants who were evaluable for specified categories. | Posted | Number | 95% Confidence Interval | percent | Up to 60 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Participants With Body-mass Index (BMI) >=30 Kilograms Per Square Meter (kg/m^2) When the Diagnosis of CAD by ICA Was the Standard of Truth | Sensitivity:TP/(TP+FN). TP:participants with abnormal PET MPI and disease positive by truth standard and FN:participants with normal PET MPI and disease positive by truth standard. Specificity:TN/(TN+ FP). TN:participants with normal PET MPI and disease negative by truth standard and FP:participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of >=50% in >=1 coronary artery or major branch of coronary artery determined by QCA analysis. Participants considered to have CAD if QCA revealed >=50% stenosis of >=1 major coronary artery or major branch. Sensitivity, specificity calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. Sensitivity, specificity of Flurpiridaz (18F) PET MPI compared to SPECT MPI with QCA as standard of truth at >=50% stenosis threshold for participants(BMI>=30 kg/m^2) reported by reader and majority rule. | The SMITT population included the participants who completed the rest and stress SPECT MPI (if the participant's SPECT MPI was "off-study," that SPECT MPI had to meet minimal quality standards, as specified by the imaging core lab). Here, "overall number of participants analyzed" signifies participants who were analyzed for a specific reader (combined sensitivity or specificity) and "number analyzed" signifies participants who were evaluable for specified categories. | Posted | Number | 95% Confidence Interval | percent | Up to 60 days |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Sensitivity and Specificity of Flurpiridaz (18F) Injection PET MPI Compared SPECT MPI for Diabetic Participants When the Diagnosis of CAD by ICA Was the Standard of Truth | Sensitivity:TP/(TP+FN). TP:participants with abnormal PET MPI and disease positive by truth standard and FN:participants with normal PET MPI and disease positive by truth standard. Specificity:TN/(TN+ FP). TN:participants with normal PET MPI and disease negative by truth standard and FP:participants with abnormal PET MPI and disease negative by truth standard. Truth standard was presence of CAD as evidenced by presence of stenosis of >=50% in >=1 coronary artery or major branch of coronary artery determined by QCA analysis. Participants considered to have CAD if QCA revealed >=50% stenosis of >=1 major coronary artery or major branch. Sensitivity and specificity calculated for 3 readers and majority rule using each participant judgement (positive or negative) by at least 2 of 3 readers. Sensitivity, specificity of Flurpiridaz (18F) PET MPI compared to SPECT MPI with QCA as standard of truth at >=50% stenosis threshold for diabetic participants was reported by reader and majority rule. | The SMITT population included the participants who completed the rest and stress SPECT MPI (if the participant's SPECT MPI was "off-study," that SPECT MPI had to meet minimal quality standards, as specified by the imaging core lab). Here, "overall number of participants analyzed" signifies participants who were analyzed for a specific reader (combined sensitivity or specificity) and "number analyzed" signifies participants who were evaluable for specified categories. | Posted | Number | 95% Confidence Interval | percent | Up to 60 days |
|
From the time of informed consent to end of follow up (up to 77 days)
The Safety population consisted of all enrolled participants who received >=1 dose of Flurpiridaz (18F) Injection in the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flurpiridaz (18F): Safety Population | Participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein: 1 at rest then 1 during stress on the same day within 60 days prior to the ICA. Flurpiridaz (18F) Injection administered at rest and during stress conditions were not to exceed a total of 14 mCi (520 MBq) for an individual participant. Flurpiridaz was administered on Study Day 1. SPECT agents 99mTc-based myocardial tracers, example [99mTc]tetrofosmin or [99mTc]sestamibi were administered as per American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location. For each participant, the same stress type (pharmacologic or exercise) was used for the SPECT and Flurpiridaz (18F) Injection PET MPI. Also, if pharmacological stress was used, the same agent and the same dose of pharmacological stress agent was used for both types of imaging for the same participant. Pharmacological stress agents were administered according to the respective Package Insert (as applicable) or American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location. | 1 | 604 | 20 | 604 | 145 | 604 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Coronary artery perforation | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Vascular stent thrombosis | General disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Post procedural fever | Injury, poisoning and procedural complications | MedDRA version 24.0 | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA version 24.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Urticaria chronic | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA version 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA version 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 24.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Systematic Assessment |
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The only disclosure restriction on the PI and/or institution is that the Sponsor can review results communications prior to public release and can restrict communications regarding trial results for a period that is more than 30 days (publications/abstracts) but not to exceed 90 days (patent related issues) from the time submitted to the Sponsor to review. The PI may be asked to remove any Sponsor confidential information and/or delay publication to protect any proprietary information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Francois Tranquart, M.D., Ph.D | GE HealthCare | 447775543206 | francois.tranquart@ge.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 6, 2022 | Jun 5, 2023 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Finland |
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| France |
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| Germany |
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| Netherlands |
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| Reader 2: Sensitivity |
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| Reader 2: Specificity |
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| Reader 3: Sensitivity |
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| Reader 3: Specificity |
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| Majority Rule: Sensitivity |
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| Majority Rule: Specificity |
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Reader 1: Specificity
| One-sided z-tests |
The hypothesis tests were one-sided z-tests with a significance level of 0.025. |
| 0.0182 |
| Other |
Specificity was compared to a pre-specified threshold of 60%. |
| Reader 2: Sensitivity | One-sided z-tests | The hypothesis tests were one-sided z-tests with a significance level of 0.025. | <0.0001 | Other | Sensitivity was compared to a pre-specified threshold of 60%. |
| Reader 2: Specificity | One-sided z-tests | The hypothesis tests were one-sided z-tests with a significance level of 0.025. | 0.0002 | Other | Specificity was compared to a pre-specified threshold of 60%. |
| Reader 3: Sensitivity | One-sided z-tests | The hypothesis tests were one-sided z-tests with a significance level of 0.025. | <0.0001 | Other | Sensitivity was compared to a pre-specified threshold of 60%. |
| Reader 3: Specificity | One-sided z-tests | The hypothesis tests were one-sided z-tests with a significance level of 0.025. | 0.9970 | Other | Specificity was compared to a pre-specified threshold of 60%. |
| Majority Rule: Sensitivity | One-sided z-tests | The hypothesis tests were one-sided z-tests with a significance level of 0.025. | <0.0001 | Other | Sensitivity was compared to a pre-specified threshold of 60%. |
| Majority Rule: Specificity | One-sided z-tests | The hypothesis tests were one-sided z-tests with a significance level of 0.025. | 0.0781 | Other | Specificity was compared to a pre-specified threshold of 60%. |
Participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein: 1 at rest then 1 during stress on the same day within 60 days prior to the ICA. Flurpiridaz (18F) Injection administered at rest and during stress conditions were not to exceed a total of 14 mCi (520 MBq) for an individual participant. Flurpiridaz was administered on Study Day 1.
Pharmacological stress agents were administered according to the respective Package Insert (as applicable) or American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location.
| OG001 | SPECT MPI | SPECT agents 99mTc-based myocardial tracers, example [99mTc]tetrofosmin or [99mTc]sestamibi were administered as per American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location. For each participant, the same stress type (pharmacologic or exercise) was used for the SPECT and Flurpiridaz (18F) Injection PET MPI. Also, if pharmacological stress was used, the same agent and the same dose of pharmacological stress agent was used for both types of imaging for the same participant. Pharmacological stress agents were administered according to the respective Package Insert (as applicable) or American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location. |
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Participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein: 1 at rest then 1 during stress on the same day within 60 days prior to the ICA. Flurpiridaz (18F) Injection administered at rest and during stress conditions were not to exceed a total of 14 mCi (520 MBq) for an individual participant. Flurpiridaz was administered on Study Day 1.
Pharmacological stress agents were administered according to the respective Package Insert (as applicable) or American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location.
| OG001 | SPECT MPI | SPECT agents 99mTc-based myocardial tracers, example [99mTc]tetrofosmin or [99mTc]sestamibi were administered as per American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location. For each participant, the same stress type (pharmacologic or exercise) was used for the SPECT and Flurpiridaz (18F) Injection PET MPI. Also, if pharmacological stress was used, the same agent and the same dose of pharmacological stress agent was used for both types of imaging for the same participant. Pharmacological stress agents were administered according to the respective Package Insert (as applicable) or American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location. |
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Participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein: 1 at rest then 1 during stress on the same day within 60 days prior to the ICA. Flurpiridaz (18F) Injection administered at rest and during stress conditions were not to exceed a total of 14 mCi (520 MBq) for an individual participant. Flurpiridaz was administered on Study Day 1. Pharmacological stress agents were administered according to the respective Package Insert (as applicable) or American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location. |
| OG001 | SPECT MPI | SPECT agents 99mTc-based myocardial tracers, example [99mTc]tetrofosmin or [99mTc]sestamibi were administered as per American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location. For each participant, the same stress type (pharmacologic or exercise) was used for the SPECT and Flurpiridaz (18F) Injection PET MPI. Also, if pharmacological stress was used, the same agent and the same dose of pharmacological stress agent was used for both types of imaging for the same participant. Pharmacological stress agents were administered according to the respective Package Insert (as applicable) or American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location. |
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Participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein: 1 at rest then 1 during stress on the same day within 60 days prior to the ICA. Flurpiridaz (18F) Injection administered at rest and during stress conditions were not to exceed a total of 14 mCi (520 MBq) for an individual participant. Flurpiridaz was administered on Study Day 1.
Pharmacological stress agents were administered according to the respective Package Insert (as applicable) or American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location.
| OG001 | SPECT MPI | SPECT agents 99mTc-based myocardial tracers, example [99mTc]tetrofosmin or [99mTc]sestamibi were administered as per American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location. For each participant, the same stress type (pharmacologic or exercise) was used for the SPECT and Flurpiridaz (18F) Injection PET MPI. Also, if pharmacological stress was used, the same agent and the same dose of pharmacological stress agent was used for both types of imaging for the same participant. Pharmacological stress agents were administered according to the respective Package Insert (as applicable) or American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards corresponding to study site location. |
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