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| Name | Class |
|---|---|
| Siemens Medical Solutions | INDUSTRY |
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The overall goal of this project is to compare the absolute quantification of myocardial perfusion done by using CT myocardial perfusion imaging (CT-MPI) and the coronary flow measured by using CT Fractional Flow Reserve analysis (CT-FFR) to the gold standard represented by PET myocardial perfusion imaging (PET-MPI).
Participants will be patients who are scheduled to undergo PET Myocardial Perfusion Imaging, which is the traditional method for evaluating patients with suspected blockages or narrowing of the heart vessels (coronary artery disease) causing impaired blood to flow to the heart muscle (myocardium).
The purpose of the study is to determine and compare the newest heart imaging equipment which allows the non-invasive evaluation of coronary anatomy, coronary flow and myocardial perfusion in patients with suspected or proven coronary artery disease (CAD) with the actual gold-standard for quantitative myocardial perfusion assessment. In order to achieve this aim, the study team will compare heart scan results from a computed tomography (CT) Myocardial Perfusion Imaging (CT-MPI) scan and CT-Fractional Flow Reserve (FFR) with the actual standard clinical care represented by a PET Myocardial Perfusion Imaging (PET-MPI) study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Three imaging techniques: PET-MPI, CT-MPI, and CT-FFR | Other | Participants referred for a clinical PET-MPI will also have CT-MPI and CT-FFR imaging performed for analysis of myocardial perfusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET-MPI Protocol | Diagnostic Test | Patients with suspected CAD who are referred to a clinical PET-MPI will undergo the standard clinical protocol applied in the Emory Nuclear Medicine department. |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Blood Flow | The absolute quantification of myocardial perfusion between CT-MPI and PET-MPI is compared. Myocardial perfusion is quantified using appropriate tracer kinetic models resulting myocardial blood flow mL/g/min. | Day of PET-MPI Scan, and Day of CT-MPI and CT-FFR Scans (up to 90 days) |
| Coronary Flow Per CT-FFR | Coronary flow is measured using the CT-FFR calculation with the CCTA scans. CT-FFR measures blood flow through coronary arteries and is used clinically to quantify the severity of CAD to determine further interventions. CT-FFR is the ratio between the blood flow (BF) in a diseased artery and a normal artery. Clinically, the CT-FFR calculation is only useful in patients with intermediate stenosis because stenosis below intermediate results in a value that is near zero and the calculation cannot be performed when stenosis is complete. The normal range for CT-FFR is greater than 0.80, values of 0.76 to 0.80 are borderline while values of 0.75 or less are associated with a high likelihood of reduced blood flow (ischemia). | Day of CT-MPI and CCTA scans |
| Sensitivity of Myocardial Perfusion Abnormalities Diagnosis | The accuracy of detection of myocardial perfusion abnormalities is compared between PET-MPI, CT-MPI, CCTA, and CT-FFR approach. Diagnostic accuracy using CT-MPI, CCTA and CT-FFR is calculated as sensitivity (true positives) with PET as the reference standard. | Day 1 (day of scans) |
| Specificity of Myocardial Perfusion Abnormalities Diagnosis | The accuracy of detection of myocardial perfusion abnormalities is compared between PET-MPI, CT-MPI, CCTA, and CT-FFR approach. Diagnostic accuracy using CT-MPI, CCTA and CT-FFR is calculated as specificity (true negatives) with PET as the reference standard. | Day 1 (day of scans) |
| Area Under the Curve (AUC) for Detection of Myocardial Perfusion Abnormalities |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or nursing females. The possibility of pregnancy will be excluded by testing (serum or urine ßHCG) within 24 hours before study agent administration, or if the woman has previous surgical sterilization, or if the woman is post-menopausal, with minimum one (1) year history without menses.
Currently taking or has taken within 48 hours the following excluded medications:
Acute psychiatric disorder
Unwilling to comply with the requirements of the protocol
Previously entered this study
Known hypersensitivity to iodinated contrast material, beta-blockers, or pharmaceutical stressors used in this study
Suffers from claustrophobia
Impaired renal function (GFR < 45 ml/min)
Acute hypotension (<100 mm Hg systolic)
2nd or 3rd degree atrioventricular (AV) block
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| Name | Affiliation | Role |
|---|---|---|
| Carlo De Cecco, MD, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
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Participants were recruited from Emory University Hospital in Atlanta, Georgia, USA. Participant enrollment began June 16, 2021 and all follow-up assessments were completed by September 24, 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Three Imaging Techniques: PET-MPI, CT-MPI, and CCTA for CT-FFR Calculation | Participants referred for a clinical positron emission tomography myocardial perfusion imaging (PET-MPI), the gold standard for evaluating patients with suspected coronary blockages or coronary artery disease, also attend a study visit where they have computed tomography (CT) myocardial perfusion imaging (CT-MPI) and coronary CT angiography for calculation of CT fractional flow reserve (CT-FFR) imaging performed for analysis of myocardial perfusion. The CT examinations are scheduled within 90 days of the standard clinical PET examination. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Three Imaging Techniques: PET-MPI, CT-MPI, and CT-FFR | Participants referred for a clinical positron emission tomography myocardial perfusion imaging (PET-MPI), the gold standard for evaluating patients with suspected coronary blockages or coronary artery disease, also attend a study visit where they have computed tomography (CT) myocardial perfusion imaging (CT-MPI) and coronary CT angiography for calculation of CT fractional flow reserve (CT-FFR) imaging performed for analysis of myocardial perfusion. The CT examinations are scheduled within 90 days of the standard clinical PET examination. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Myocardial Blood Flow | The absolute quantification of myocardial perfusion between CT-MPI and PET-MPI is compared. Myocardial perfusion is quantified using appropriate tracer kinetic models resulting myocardial blood flow mL/g/min. | PET-MPI data were lost for two participants during an equipment move. | Posted | Mean | Standard Deviation | mL/g/min | Day of PET-MPI Scan, and Day of CT-MPI and CT-FFR Scans (up to 90 days) |
|
Information on adverse events was collected during the PET-MPI scan and during the CT-MPI and CCTA scans, for a total of two days spread over a period of up to 90 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PET-MPI | Participants referred for a clinical positron emission tomography myocardial perfusion imaging (PET-MPI), the gold standard for evaluating patients with suspected coronary blockages or coronary artery disease, also attend a study visit where they have computed tomography (CT) myocardial perfusion imaging (CT-MPI) and coronary CT angiography for calculation of CT fractional flow reserve (CT-FFR) imaging performed for analysis of myocardial perfusion. The CT examinations are scheduled within 90 days of the standard clinical PET examination. Patients with suspected CAD who are referred to a clinical PET-MPI undergo the standard clinical protocol applied in the Emory Nuclear Medicine department. PET-MPI is performed at rest and with stress. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carlo De Cecco, MD, PhD | Emory University | 404-712-7968 | carlo.dececco@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2023 | Sep 18, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D050197 | Atherosclerosis |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| C430916 | regadenoson |
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| CT-MPI | Diagnostic Test | For the CT-MPI, dynamic volume CT myocardial perfusion applying the "dynamic shuttle" mode will be used to rapidly cover the entire cardiac anatomy during infusion of a contrast medium bolus for monitoring bolus passage through the left ventricular myocardium. The "dynamic shuttle" mode consists of an image acquisition during rapid, yet smooth back-and-forth movement of the CT scanner table, so that contrast media bolus passage can be evaluated within the entire left ventricle in a time-resolved fashion. This scan acquisition will be performed during pharmacologically induced stress and during rest conditions. CT-MPI studies will be contrast medium enhanced by 50-70 ml of iodinated contrast agent, administered at a flow rate of 5 mL/s. The CT examinations are scheduled within 90 days of the standard clinical PET examination. |
|
| Coronary CT angiography (CCTA) for CT-FFR calculation | Diagnostic Test | Coronary CT angiography (CCTA) will be performed for delineation of the coronary arteries, detection of potential coronary stenosis and FFR calculation. CCTA will be performed at rest following administration of intravenous contrast agent (50-70 mL of iodinated contrast material at a flow rate of 4-5 mL/s). A total radiation dose of approximately 8 millisievert (mSv) has expected to be administered with the stress/rest protocol to the patient. The total amount of contrast agent will not exceed 140 ml. The CT examinations are scheduled within 90 days of the standard clinical PET examination. |
|
| Regadenoson | Drug | Pharmacological stress testing for the CT-MPI scan will be performed with a single injection of 0.4 mg of regadenoson (Lexiscan). |
|
|
The accuracy of detection of myocardial perfusion abnormalities is compared between PET-MPI, CT-MPI, CCTA, and CT-FFR approach. Diagnostic accuracy using CT-MPI, CCTA and CT-FFR is calculated as overall AUC with PET as the reference standard. The AUC examines the overall accuracy of a diagnostic test. Higher AUC indicates greater accuracy in detecting myocardial perfusion abnormalities with 1.0 being 100% accurate. An AUC value of 0.5 indicates that the test is as accurate as random chance. |
| Day 1 (day of scans) |
| Sensitivity of Coronary Stenosis Diagnosis | The accuracy of detection of coronary stenosis is compared between PET-MPI, CT-MPI, and CCTA with CT-FFR approach. Diagnostic accuracy is calculated as sensitivity (true positives) with CCTA as the reference standard. | Day 1 (day of scans) |
| Specificity of Coronary Stenosis Detection | The accuracy of detection of coronary stenosis is compared between PET-MPI, CT-MPI, and CCTA with CT-FFR approach. Diagnostic accuracy is calculated as specificity (true negatives) with CCTA as the reference standard. | Day 1 (day of scans) |
| Area Under the Curve for Detection of Coronary Stenosis | The accuracy of detection of coronary stenosis is compared between PET-MPI, CT-MPI, and CCTA with CT-FFR approach. Diagnostic accuracy is calculated as overall AUC with CCTA as the reference standard. The AUC examines the overall accuracy of a diagnostic test. Higher AUC indicates greater accuracy in detecting coronary stenosis with 1.0 being 100% accurate. An AUC value of 0.5 indicates that the test is as accurate as random chance. | Day 1 (day of scans) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | BMI is calculated as weight in kilograms (kg) / height in meters (m)^2 | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | PET-MPI - Rest | Participants referred for a clinical positron emission tomography myocardial perfusion imaging (PET-MPI), the gold standard for evaluating patients with suspected coronary blockages or coronary artery disease (CAD), also attend a study visit where they have computed tomography (CT) myocardial perfusion imaging (CT-MPI) and coronary CT angiography for calculation of CT fractional flow reserve (CT-FFR) imaging performed for analysis of myocardial perfusion. The CT examinations are scheduled within 90 days of the standard clinical PET examination. Patients with suspected CAD who are referred to a clinical PET-MPI undergo the standard clinical protocol applied in the Emory Nuclear Medicine department. PET-MPI is performed with stress and rest conditions. |
| OG002 | PET-MPI - Stress | Participants referred for a clinical positron emission tomography myocardial perfusion imaging (PET-MPI), the gold standard for evaluating patients with suspected coronary blockages or coronary artery disease, also attend a study visit where they have computed tomography (CT) myocardial perfusion imaging (CT-MPI) and coronary CT angiography for calculation of CT fractional flow reserve (CT-FFR) imaging performed for analysis of myocardial perfusion. The CT examinations are scheduled within 90 days of the standard clinical PET examination. Patients with suspected CAD who are referred to a clinical PET-MPI undergo the standard clinical protocol applied in the Emory Nuclear Medicine department. PET-MPI is performed with stress and rest conditions. |
|
|
| Primary | Coronary Flow Per CT-FFR | Coronary flow is measured using the CT-FFR calculation with the CCTA scans. CT-FFR measures blood flow through coronary arteries and is used clinically to quantify the severity of CAD to determine further interventions. CT-FFR is the ratio between the blood flow (BF) in a diseased artery and a normal artery. Clinically, the CT-FFR calculation is only useful in patients with intermediate stenosis because stenosis below intermediate results in a value that is near zero and the calculation cannot be performed when stenosis is complete. The normal range for CT-FFR is greater than 0.80, values of 0.76 to 0.80 are borderline while values of 0.75 or less are associated with a high likelihood of reduced blood flow (ischemia). | Only one participant met clinical guidelines for the calculation of CT-FFR by having intermediate stenosis. One participant had stenosis too high to calculate CT-FFR while the remaining 18 participants had too little stenosis for an informative calculation. | Posted | Number | ratio | Day of CT-MPI and CCTA scans |
|
|
|
| Primary | Sensitivity of Myocardial Perfusion Abnormalities Diagnosis | The accuracy of detection of myocardial perfusion abnormalities is compared between PET-MPI, CT-MPI, CCTA, and CT-FFR approach. Diagnostic accuracy using CT-MPI, CCTA and CT-FFR is calculated as sensitivity (true positives) with PET as the reference standard. | This analysis includes participants with a PET-MPI result available. PET-MPI data were lost for two participants during an equipment move. Only one participant met clinical guidelines for the calculation of CT-FFR by having intermediate stenosis, however, the gold standard PET exam provided an incorrect diagnosis thus calculating sensitivity cannot correctly estimate the accuracy of CT-FFR. | Posted | Number | percentage of true postive cases | Day 1 (day of scans) |
|
|
|
| Primary | Specificity of Myocardial Perfusion Abnormalities Diagnosis | The accuracy of detection of myocardial perfusion abnormalities is compared between PET-MPI, CT-MPI, CCTA, and CT-FFR approach. Diagnostic accuracy using CT-MPI, CCTA and CT-FFR is calculated as specificity (true negatives) with PET as the reference standard. | This analysis includes participants with a PET-MPI result available. PET-MPI data were lost for two participants during an equipment move. Only one participant met clinical guidelines for the calculation of CT-FFR by having intermediate stenosis, however, the gold standard PET exam provided an incorrect diagnosis thus calculating specificity cannot correctly estimate the accuracy of CT-FFR. | Posted | Number | percentage of true negative cases | Day 1 (day of scans) |
|
|
|
| Primary | Area Under the Curve (AUC) for Detection of Myocardial Perfusion Abnormalities | The accuracy of detection of myocardial perfusion abnormalities is compared between PET-MPI, CT-MPI, CCTA, and CT-FFR approach. Diagnostic accuracy using CT-MPI, CCTA and CT-FFR is calculated as overall AUC with PET as the reference standard. The AUC examines the overall accuracy of a diagnostic test. Higher AUC indicates greater accuracy in detecting myocardial perfusion abnormalities with 1.0 being 100% accurate. An AUC value of 0.5 indicates that the test is as accurate as random chance. | This analysis includes participants with a PET-MPI result available. PET-MPI data were lost for two participants during an equipment move. | Posted | Number | probabliity of accurate detection | Day 1 (day of scans) |
|
|
|
| Primary | Sensitivity of Coronary Stenosis Diagnosis | The accuracy of detection of coronary stenosis is compared between PET-MPI, CT-MPI, and CCTA with CT-FFR approach. Diagnostic accuracy is calculated as sensitivity (true positives) with CCTA as the reference standard. | This analysis includes participants with a PET-MPI result available. PET-MPI data were lost for two participants during an equipment move. | Posted | Number | percentage of true postive cases | Day 1 (day of scans) |
|
|
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| Primary | Specificity of Coronary Stenosis Detection | The accuracy of detection of coronary stenosis is compared between PET-MPI, CT-MPI, and CCTA with CT-FFR approach. Diagnostic accuracy is calculated as specificity (true negatives) with CCTA as the reference standard. | This analysis includes participants with a PET-MPI result available. PET-MPI data were lost for two participants during an equipment move. Specificity could not be calculated in the CCTA with CT-FFR Calculation study arm as there was not a participant negative for coronary stenosis per the reference standard. | Posted | Number | percentage of true negative cases | Day 1 (day of scans) |
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|
|
| Primary | Area Under the Curve for Detection of Coronary Stenosis | The accuracy of detection of coronary stenosis is compared between PET-MPI, CT-MPI, and CCTA with CT-FFR approach. Diagnostic accuracy is calculated as overall AUC with CCTA as the reference standard. The AUC examines the overall accuracy of a diagnostic test. Higher AUC indicates greater accuracy in detecting coronary stenosis with 1.0 being 100% accurate. An AUC value of 0.5 indicates that the test is as accurate as random chance. | This analysis includes participants with a PET-MPI result available. PET-MPI data were lost for two participants during an equipment move. | Posted | Number | probabliity of accurate detection | Day 1 (day of scans) |
|
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | CT-MPI | Participants referred for a clinical positron emission tomography myocardial perfusion imaging (PET-MPI), the gold standard for evaluating patients with suspected coronary blockages or coronary artery disease, also attend a study visit where they have computed tomography (CT) myocardial perfusion imaging (CT-MPI) and coronary CT angiography for calculation of CT fractional flow reserve (CT-FFR) imaging performed for analysis of myocardial perfusion. The CT examinations are scheduled within 90 days of the standard clinical PET examination. For the CT-MPI, dynamic volume CT myocardial perfusion applying the "dynamic shuttle" mode is used to rapidly cover the entire cardiac anatomy during infusion of a contrast medium bolus for monitoring bolus passage through the left ventricular myocardium. This scan acquisition is performed during pharmacologically induced stress and during rest conditions. CT-MPI studies are contrast medium enhanced by an iodinated contrast agent. Pharmacological stress testing for the CT-MPI scan is performed with a single injection of 0.4 mg of regadenoson. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | CCTA With CT-FFR Calculation | Participants referred for a clinical positron emission tomography myocardial perfusion imaging (PET-MPI), the gold standard for evaluating patients with suspected coronary blockages or coronary artery disease, also attend a study visit where they have computed tomography (CT) myocardial perfusion imaging (CT-MPI) and coronary CT angiography for calculation of CT fractional flow reserve (CT-FFR) imaging performed for analysis of myocardial perfusion. The CT examinations are scheduled within 90 days of the standard clinical PET examination. Coronary CT angiography (CCTA) is performed for delineation of the coronary arteries, detection of potential coronary stenosis and fractional flow reserve (FFR) calculation. CCTA is performed at rest following administration of intravenous contrast agent. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D014652 |
| Vascular Diseases |