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| Name | Class |
|---|---|
| Duke Clinical Research Institute | OTHER |
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The objective of the PLATFORM Study is to compare clinical outcomes, resource utilization, and quality of life (QOL) of FFRCT-guided evaluation versus standard practice evaluation in patients with suspected CAD in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis of CAD
The OVERALL OBJECTVE of this post-market, multicenter, longitudinal, prospective, consecutive cohort study is to compare clinical outcomes, resource utilization, and quality of life (QOL) in subjects receiving standard practice evaluation and treatment versus subjects receiving FFRCT-guided evaluation and treatment in subjects with suspected CAD in order to further inform patients, health care providers, and other stakeholders about which technologies are most effective and efficient in the diagnosis of CAD. Cohort 1 of this study will assess outcomes incorporating standard practice evaluation and Cohort 2 will assess outcomes incorporating FFRCT-guided evaluation. Each Cohort will be further delineated based upon initial presentation, whereas subjects presenting for initial non-invasive testing will be designated as Cohorts 1A and 2A; and subjects already referred for ICA will be designated as Cohorts 1B and 2B.
SPECIFIC OBJECTIVES for sequential cohort comparisons:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - Standard of Care | Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of each subject considered for percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG), the investigator and the institution's heart team will review clinical data and results of the diagnostic tests to recommend a treatment strategy, according to the institution's standard practice. Cohort 1 of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD. Subjects will be followed for one year after enrollment. | ||
| Cohort 2 - FFRCT-guided | Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of subjects considered for PCI and/or CABG, the investigator and the institution's heart team will review the results of all available diagnostic tests, including cCTA and FFRCT, and will recommend a treatment strategy accordingly. FFRCT is a non-invasive method to evaluate the hemodynamic significance of coronary artery lesions. FFRCT calculates FFR from subject-specific cCTA data using computational fluid dynamics under rest and simulated maximal coronary hyperemic conditions. FFRCT values range between 0 and 1, and values ≤0.80 are considered hemodynamically (HD)-significant. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Negative Invasive Coronary Angiography | The primary endpoint of the PLATFORM Study is 90 day (+30/-15 days) rate of coronary angiogram showing no stenosis > 50% in a vessel > 2.0 mm by Quantitative Coronary Angiography (QCA), or no invasively-measured FFR < 0.80 in a segment distal to a stenosis in a vessel > 2.0 mm by QCA between Cohort 1 and 2. | 90 Days from first test |
| Measure | Description | Time Frame |
|---|---|---|
| Number of MACE | 90 days (+30/-30 days) Cohort 1 and Cohort 2 Major Adverse Coronary Event (MACE) rates, defined as:
| 90 days from first test |
| Number of MACE or Vascular Complications |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects referred with intermediate likelihood of obstructive CAD with an Updated Diamond-Forrester (UDF) risk score 20-80% with symptomatic, suspected CAD
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| Name | Affiliation | Role |
|---|---|---|
| Gianluca Pontone, MD | Centro Cardiologico Monzino | Principal Investigator |
| Pamela Douglas, MD | Duke University | Principal Investigator |
| Bernard de Bruyne, MD, PHD | Cardiovascular Center Aalst | Principal Investigator |
| Mark Hlatky, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HeartFlow, Inc | Redwood City | California | 94063 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27470449 | Derived | Douglas PS, De Bruyne B, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Chiswell K, Cyr D, Wilk A, Wang F, Rogers C, Hlatky MA; PLATFORM Investigators. 1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study. J Am Coll Cardiol. 2016 Aug 2;68(5):435-445. doi: 10.1016/j.jacc.2016.05.057. | |
| 26475205 |
| Label | URL |
|---|---|
| 1-Year Outcomes of FFRCT-Guided Care in Patients With Suspected Coronary Disease: The PLATFORM Study | View source |
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Patients were eligible for enrollment if they were symptomatic, had an intermediate likelihood of CAD, did not have an established diagnosis of CAD, and were referred for clinically indicated testing to evaluate CAD. Patients referred for noninvasive testing were enrolled in a separate stratum than patients referred for invasive testing. The choice to refer the patient for invasive testing rather than noninvasive testing was made by the local clinicians before enrollment in the study.
Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of each subject considered for percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG), the investigator and the institution's heart team will review clinical data and results of the diagnostic tests to recommend a treatment strategy, according to the institution's standard practice.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-invasive (Cohort 2) Usual Care | (Cohort 2) Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of subjects considered for PCI and/or CABG, the investigator and the institution's heart team will review the results of all available diagnostic tests, including cCTA and FFRCT, and will recommend a treatment strategy accordingly. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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90 days (+30/-30 days) Major Adverse Coronary Event (MACE) rates, defined as: all cause death, non-fatal MI, unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization and vascular complications (related to any coronary testing or procedure).This secondary endpoint compared the rates of MACE and vascular events across all subjects in Cohort 1 vs Cohort 2, Cohort 1A vs Cohort 2A and Cohort 1B vs Cohort 2B. The rates of MACE and vascular events were calculated by dividing the number of subjects with MACE and vascular events by the total number of subjects assigned to each analysis population. |
| 90 days from first test |
| Number of Participants With Resource (CV Test Types Performed) Utilization at 90 Days | Comparison of Resource utilization between cohort 1 and cohort 2 at 90 days (+/- 30 days):
| 90 days from first test |
| Number of Participants With Medications Used by Type | Comparison of medication use between cohort 1A, 1B and cohort 2A, 2B at 90 days (+/- 15 days) | at 90 days |
| Stanford |
| California |
| 94305 |
| United States |
| Duke University Clinical Research Institution | Durham | North Carolina | 27705 | United States |
| LKH-GRAZ-West - Department of Cardiology | Graz | A-8020 | Austria |
| Innsbruck Medical University, Department of Radiology II | Innsbruck | A-6020 | Austria |
| Cardiovascular Center Aalst | Aalst | Belgium |
| Aarhus University Hospital Skejby | Aarhus | 8200 | Denmark |
| CHU Brest - Hopital de Cardiologie | Brest | 29609 | France |
| Cardiovascular Hospital -Interventional Cardiology Dept, Hospices Civils de Lyon and Claude Bernard University France | Lyon | 69677 | France |
| Heart Center Leipzig GmbH | Leipzig | 04289 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz | 55131 | Germany |
| Deutsches Herzzentrum München - ISAResearch Centre | Munich | 80636 | Germany |
| Centro Cardiologico Monzino | Milan | 20154 | Italy |
| Freeman Hospital - Therapeutics & Cardiac Research Team | Newcastle upon Tyne | NE7 7DN | United Kingdom |
| University Hospital Southampton NHS Foundation Trust | Southampton | SO16 6YD | United Kingdom |
| Derived |
| Hlatky MA, De Bruyne B, Pontone G, Patel MR, Norgaard BL, Byrne RA, Curzen N, Purcell I, Gutberlet M, Rioufol G, Hink U, Schuchlenz HW, Feuchtner G, Gilard M, Andreini D, Jensen JM, Hadamitzky M, Wilk A, Wang F, Rogers C, Douglas PS; PLATFORM Investigators. Quality-of-Life and Economic Outcomes of Assessing Fractional Flow Reserve With Computed Tomography Angiography: PLATFORM. J Am Coll Cardiol. 2015 Dec 1;66(21):2315-2323. doi: 10.1016/j.jacc.2015.09.051. Epub 2015 Oct 14. |
| Quality-of-Life and Economic Outcomes of Assessing Fractional Flow Reserve With Computed Tomography Angiography: PLATFORM | View source |
| FG001 | Non-invasive Cohort (Cohort 2) FFRCT | The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography. |
| FG002 | Invasive Cohort (Cohort 1) Usual Care | (Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD. |
| FG003 | Invasive Cohort (Cohort 1) FFRCT | The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Invasive Cohort (Cohort 1) Usual Care | (Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD. |
| BG001 | Invasive Cohort (Cohort 1) FFRCT | The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography. |
| BG002 | Non-invasive (Cohort 2) Usual Care | (Cohort 2) Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of subjects considered for PCI and/or CABG, the investigator and the institution's heart team will review the results of all available diagnostic tests, including cCTA and FFRCT, and will recommend a treatment strategy accordingly. |
| BG003 | Non-invasive Cohort (Cohort 2) FFRCT | The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Diabetes | Count of Participants | Participants |
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| Current smoker | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
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| Hyperlipidemia | Count of Participants | Participants |
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| Atypical angina | Count of Participants | Participants |
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| Prior noninvasive testing | Count of Participants | Participants |
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| Pre-test probability of CAD | Count of Participants | Participants |
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| 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 | Number of Participants With Negative Invasive Coronary Angiography | The primary endpoint of the PLATFORM Study is 90 day (+30/-15 days) rate of coronary angiogram showing no stenosis > 50% in a vessel > 2.0 mm by Quantitative Coronary Angiography (QCA), or no invasively-measured FFR < 0.80 in a segment distal to a stenosis in a vessel > 2.0 mm by QCA between Cohort 1 and 2. | ICA - Invasive coronary angiography. Independent core laboratories performed quantitative coronary angiography. | Posted | Count of Participants | Participants | 90 Days from first test |
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| Secondary | Number of MACE | 90 days (+30/-30 days) Cohort 1 and Cohort 2 Major Adverse Coronary Event (MACE) rates, defined as:
| The analysis population was defined as all subjects who were enrolled into the study. Safety was monitored throughout the study. The low number of MACE events made it impossible to analyze the powered secondary endpoint. None of the events were related to the FFRCT. | Posted | Count of Participants | Participants | 90 days from first test |
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| Secondary | Number of MACE or Vascular Complications | 90 days (+30/-30 days) Major Adverse Coronary Event (MACE) rates, defined as: all cause death, non-fatal MI, unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization and vascular complications (related to any coronary testing or procedure).This secondary endpoint compared the rates of MACE and vascular events across all subjects in Cohort 1 vs Cohort 2, Cohort 1A vs Cohort 2A and Cohort 1B vs Cohort 2B. The rates of MACE and vascular events were calculated by dividing the number of subjects with MACE and vascular events by the total number of subjects assigned to each analysis population. | The analysis population was defined as all subjects who were enrolled into the study. It is important to note that none of the adverse events reported throughout the study were related to FFRCT. | Posted | Count of Participants | Participants | 90 days from first test |
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| Secondary | Number of Participants With Resource (CV Test Types Performed) Utilization at 90 Days | Comparison of Resource utilization between cohort 1 and cohort 2 at 90 days (+/- 30 days):
| Posted | Count of Participants | Participants | 90 days from first test |
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| Secondary | Number of Participants With Medications Used by Type | Comparison of medication use between cohort 1A, 1B and cohort 2A, 2B at 90 days (+/- 15 days) | Values are the total number of patients who used particular medication (multiple medication types might be used per each patient) | Posted | Number | participants (total count) | at 90 days |
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Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
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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 | Non-invasive (Cohort 2) Usual Care | (Cohort 2) Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of subjects considered for PCI and/or CABG, the investigator and the institution's heart team will review the results of all available diagnostic tests, including cCTA and FFRCT, and will recommend a treatment strategy accordingly. | 0 | 100 | 2 | 100 | 6 | 100 |
| EG001 | Non-invasive Cohort (Cohort 2) FFRCT | The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography. | 0 | 104 | 1 | 104 | 13 | 104 |
| EG002 | Invasive Cohort (Cohort 1) Usual Care | (Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD. | 1 | 187 | 6 | 187 | 137 | 187 |
| EG003 | Invasive Cohort (Cohort 1) FFRCT | The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography. | 0 | 193 | 9 | 193 | 24 | 193 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| All-cause death | Cardiac disorders | Systematic Assessment |
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| Nonfatal MI | Cardiac disorders | Systematic Assessment |
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| Hospitalization with urgent revascularization | Cardiac disorders | Systematic Assessment |
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| MACE or vascular complications | Cardiac disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Invasive catheterization without obstructive CAD | Cardiac disorders | Systematic Assessment | CAD - coronary artery disease. Obstructive CAD determined as 20%-80% stenosis by core lab quantitative coronary angiography (at 90 days). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Clinical | HeartFlow | 408-314-2335 | smullen@heartflow.com |
| 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 |
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| Male |
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(Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD. |
| OG003 | Invasive Cohort (Cohort 1) FFRCT | The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography. |
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| OG002 | Invasive Cohort (Cohort 1) Usual Care | (Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD. |
| OG003 | Invasive Cohort (Cohort 1) FFRCT | The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography. |
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