An interventional study of cCTA with selective FFRct in Coronary Artery Disease, sponsored by HeartFlow, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-29.
Sponsored by HeartFlow, Inc. · Not applicable, Interventional, and Other
The study will be a prospective, pragmatic, randomized clinical trial of the comparative effectiveness of diagnostic evaluation strategies for stable CAD, to be performed in outpatient settings, including primary care and cardiology practices.
Objective was to test a modified initial cCTA strategy (PS) designed to improve clinical efficiency vs usual testing (UT). Patients from 65 North American and European sites with stable symptoms of suspected coronary artery disease (CAD) and no prior testing were randomly assigned 1:1 to precision strategy PS or UT. PS incorporated the Prospective Multicenter Imaging Study for the Evaluation of Chest Pain (PROMISE) minimal risk score to quantitatively select minimal-risk participants for deferred testing, assigning all others to cCTA with selective CT-derived fractional flow reserve (FFR-CT). UT included site-selected stress testing or catheterization. Site clinicians determined subsequent care.
5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's enrollment of 2,103 is above the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →HeartFlow, Inc. is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
If prior CV testing has occurred, it must have been performed greater than one year prior to randomization, and the following must be met:
Safe performance of cCTA:
Exclusion criteria (all must be absent):
Noninvasive or invasive CV testing for CAD within 1 year. CV testing for CAD refers to any stress tests, invasive coronary angiography (ICA) and cCTA (including calcium scoring) only.
a. Resting ECG, resting echocardiogram and resting CMR (MRI) are not exclusionary regardless of when were performed
For participants randomized to usual care, the participant's care team will select the specific noninvasive stress test (exercise electrocardiogram, stress nuclear imaging \[including PET\], stress MR, or stress echocardiogram); OR invasive test: (direct to diagnostic catheterization).
Participants randomized to a precision strategy will be assigned to either guideline-recommended care without immediately planned testing (low risk) or cCTA with selective FFRct (elevated risk) using a risk tool based on pretest clinical characteristics derived from the PROMISE trial and validated in SCOT-HEART trial. Participants assigned to guideline-recommended care without planned testing will be treated with preventive and antianginal medical treatment per guideline recommendations and clinical judgment and followed without testing.
Diagnostic Test: cCTA with selective FFRct
PRECISE will evaluate whether a precision evaluation strategy that combines contemporary risk stratification using the PROMISE Risk Tool with functional and anatomic non-invasive evaluation with cCTA with selective FFRct can improve outcomes over usual care in stable chest pain patients while safely deferring further testing in low-risk patients and reducing cost overall
Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease
The centrally adjudicated (by Clinical Events Committee) primary end point was a composite of clinical efficiency as a gatekeeper to invasive testing (catheterization without obstructive CAD) and safety (death, non fatal myocardial infarction \[MI\]) at 1 year. Invasive cardiac catheterization without obstructive coronary artery disease defined as the absence of any ≥50% stenosis or hemodynamic indication of significance (no FFR ≤0.80 or iFR≤0.89) in any major epicardial vessel including side branches ≥2 mm in diameter, as determined by core-lab adjudicated quantitative coronary angiography (QCA) or if QCA not performed, by site report. A detailed description and information on the definitions of primary endpoint component definitions is provided in the current version of the study Protocol, Statistical Analysis Plan, and the published trial design article.
Time frame: 1 year
Number of Unplanned Hospitalizations (Including Admissions With Death or MI)
Urgent and unscheduled hospitalizations for cardiovascular causes include hospitalization for ischemic heart disease including myocardial infarction and unstable angina, cerebrovascular disease including stroke and TIA, heart failure, acute and/or critical limb ischemia, other thrombotic events including pulmonary embolism, arrhythmias, cardiac arrest and other clear cardiovascular causes for hospitalization that do not meet the criteria for the specific events listed here (e.g., hospitalization for acute cardiac chest pain that does not meet the criteria for MI or UA).
Time frame: 1 year
Number of Catheterization and Revascularization Procedures
Catheterization efficiency was defined as the proportion of invasive cardiac catheterization patients who undergo revascularization (PCI or CABG) within 6 months. Revascularization may occur either percutaneously (PCI) or surgically (CABG) or as hybrid (PCI and CABG). For PCI, any intervention on a lesion in the coronary tree (including angioplasty, stenting, intravascular lithotripsy) whether successful or not will be considered a revascularization. For CABG the start of the surgical procedure (skin incision) was considered as CABG, whether the procedure was successful or not. Staged revascularization was considered as one revascularization event.
Time frame: 1 year
Number of Participants With Preventive Medication Use
Lipid-lowering agents included statins, ezetimibe, PCSK9 inhibitors. Antiplatelet agents included aspirin, clopidogrel, ticagrelor, or prasugrel. Antihypertensive medications included calcium channel blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, angiotensin-neprilysin inhibitor, beta blockers, nitrates, or diuretics.
Time frame: 1 Year
Number of Participants With Quality of Life (Angina Frequency) Assessment
Overall health status was assessed briefly using the EQ-5D-5L, a standardized generic measure that can also be used to link specific health states to general population-based utilities. The EQ-5D-5L consists of two parts: (1) a descriptive assessment of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take one of five responses corresponding to the level of severity within each dimension, and (2) a self-rating 0- 100 "thermometer" of current health-related quality of life. The proportion of participants with frequent angina (Seattle Angina Questionnaire angina frequency score \<80).
Time frame: 1 year
Cumulative Radiation Exposure From All Cardiovascular Procedures (12 M), MilliSievert (mSv)
The cumulative radiation exposure over the 12 months following Randomization was calculated based on each participant's exposure to radiation for cardiovascular care. If data are missing in \> 80% or more of the diagnostic and procedural testing, a single fixed estimate of radiation based on the literature will be used to impute. Given high missingness in catheterization data, a fixed estimate of 6.6 mSv and 4.1 mSv was used for catheterization with and without revascularization, respectively, based on recent trial data.
Time frame: 1 year
Participants were randomly assigned 1:1 to precision strategy (PS) or usual testing (UT), stratified by site, intended first test if randomly assigned to UT, and minimal vs moderate-high risk using the validated PROMISE minimal risk score(PMRS). All PS and UT testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.
| Milestone | Precision Strategy (PS) | Usual Testing (UT) |
|---|---|---|
| Started | 1057 | 1046 |
| Completed | 1057 | 1046 |
| Not completed | 0 | 0 |
The centrally adjudicated (by Clinical Events Committee) primary end point was a composite of clinical efficiency as a gatekeeper to invasive testing (catheterization without obstructive CAD) and safety (death, non fatal myocardial infarction \[MI\]) at 1 year. Invasive cardiac catheterization without obstructive coronary artery disease defined as the absence of any ≥50% stenosis or hemodynamic indication of significance (no FFR ≤0.80 or iFR≤0.89) in any major epicardial vessel including side branches ≥2 mm in diameter, as determined by core-lab adjudicated quantitative coronary angiography (QCA) or if QCA not performed, by site report. A detailed description and information on the definitions of primary endpoint component definitions is provided in the current version of the study Protocol, Statistical Analysis Plan, and the published trial design article.
| number of events | Precision Strategy (PS) | Usual Testing (UT) |
|---|---|---|
| Primary Composite End Point | 44 | 118 |
| Death or Nonfatal Myocardial Infarction (first event only) | 18 | 12 |
| Death from any cause | 5 | 7 |
| Nonfatal Myocardial Infarction | 13 | 5 |
| Invasive cardiac catheterization without Obstructive coronary disease | 27 | 107 |
Urgent and unscheduled hospitalizations for cardiovascular causes include hospitalization for ischemic heart disease including myocardial infarction and unstable angina, cerebrovascular disease including stroke and TIA, heart failure, acute and/or critical limb ischemia, other thrombotic events including pulmonary embolism, arrhythmias, cardiac arrest and other clear cardiovascular causes for hospitalization that do not meet the criteria for the specific events listed here (e.g., hospitalization for acute cardiac chest pain that does not meet the criteria for MI or UA).
| number of events | Precision Strategy (PS) | Usual Testing (UT) |
|---|---|---|
| Cardiovascular | 31 | 21 |
| For Unstable Angina | 9 | 5 |
Catheterization efficiency was defined as the proportion of invasive cardiac catheterization patients who undergo revascularization (PCI or CABG) within 6 months. Revascularization may occur either percutaneously (PCI) or surgically (CABG) or as hybrid (PCI and CABG). For PCI, any intervention on a lesion in the coronary tree (including angioplasty, stenting, intravascular lithotripsy) whether successful or not will be considered a revascularization. For CABG the start of the surgical procedure (skin incision) was considered as CABG, whether the procedure was successful or not. Staged revascularization was considered as one revascularization event.
| number of events | Precision Strategy (PS) | Usual Testing (UT) |
|---|---|---|
| Invasive catheterization | 135 | 177 |
| Rate of finding obstructive CAD on catheterization | 108 | 70 |
| Total Revascularizations | 97 | 54 |
| PCI | 77 | 37 |
| CABG | 21 | 18 |
Lipid-lowering agents included statins, ezetimibe, PCSK9 inhibitors. Antiplatelet agents included aspirin, clopidogrel, ticagrelor, or prasugrel. Antihypertensive medications included calcium channel blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, angiotensin-neprilysin inhibitor, beta blockers, nitrates, or diuretics.
| Participants | Precision Strategy (PS) | Usual Testing (UT) |
|---|---|---|
| Antiplatelet | 321 | 237 |
| Lipid-lowering | 450 | 365 |
| Anti-hypertensive | 504 | 455 |
Overall health status was assessed briefly using the EQ-5D-5L, a standardized generic measure that can also be used to link specific health states to general population-based utilities. The EQ-5D-5L consists of two parts: (1) a descriptive assessment of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take one of five responses corresponding to the level of severity within each dimension, and (2) a self-rating 0- 100 "thermometer" of current health-related quality of life. The proportion of participants with frequent angina (Seattle Angina Questionnaire angina frequency score \<80).
| Participants | Precision Strategy (PS) | Usual Testing (UT) |
|---|---|---|
| More frequent angina: all participants | 141 | 140 |
| More frequent angina: participants with typical angina | 50 | 40 |
The cumulative radiation exposure over the 12 months following Randomization was calculated based on each participant's exposure to radiation for cardiovascular care. If data are missing in \> 80% or more of the diagnostic and procedural testing, a single fixed estimate of radiation based on the literature will be used to impute. Given high missingness in catheterization data, a fixed estimate of 6.6 mSv and 4.1 mSv was used for catheterization with and without revascularization, respectively, based on recent trial data.
| mSv | Precision Strategy (PS) | Usual Testing (UT) |
|---|---|---|
| Cumulative Radiation Exposure From All Cardiovascular Procedures (12 M), MilliSievert (mSv) | 5.2 ± 5.4 | 4.7 ± 6.0 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Precision Strategy (PS) | 5/1,057 (0.5%) | 40/1,057 (3.8%) | 13/1,057 (1.2%) |
| Usual Testing (UT) | 7/1,046 (0.7%) | 30/1,046 (2.9%) | 43/1,046 (4.1%) |
| Event | Precision Strategy (PS) | Usual Testing (UT) |
|---|---|---|
| Unplanned CV hospitalization excluding admissions with MI or deathCardiac disorders | 22/1057 | 18/1046 |
| Myocardial Infarction (MI - non-fatal)Cardiac disorders | 13/1057 | 5/1046 |
| Death from any causeCardiac disorders | 5/1057 | 7/1046 |
| Event | Precision Strategy (PS) | Usual Testing (UT) |
|---|---|---|
| Minor test and procedural complications by test typeInjury, poisoning and procedural complications | 9/1057 | 37/1046 |
| Major test and procedural complications by test typeInjury, poisoning and procedural complications | 4/1057 | 6/1046 |
| HeartFlow Analysis (FFRCT) - Customer Support InvestigationsProduct Issues | 0/1057 | 0/1046 |
| Age, Continuous(years) | Precision Strategy (PS) | Usual Testing (UT) | Total |
|---|---|---|---|
| Mean | 58.0 ± 11.5 | 58.9 ± 11.6 | 58.4 ± 11.5 |
| Sex: Female, Male(Participants) | Precision Strategy (PS) | Usual Testing (UT) | Total |
|---|---|---|---|
| Female | 508 | 539 | 1047 |
| Male | 549 | 507 | 1056 |
| Race (NIH/OMB)(Participants) | Precision Strategy (PS) | Usual Testing (UT) | Total |
|---|---|---|---|
| American Indian or Alaska Native | NA | NA | NA |
| Asian | NA | NA | NA |
| Native Hawaiian or Other Pacific Islander | NA | NA | NA |
| Black or African American | NA | NA | NA |
| White | 892 | 875 | 1767 |
| More than one race | NA | NA | NA |
| Unknown or Not Reported | NA | NA | NA |
| Hypertension(Participants) | Precision Strategy (PS) | Usual Testing (UT) | Total |
|---|---|---|---|
| Count of participants | 642 | 606 | 1248 |
| Body mass index(kg/m^2) | Precision Strategy (PS) | Usual Testing (UT) | Total |
|---|---|---|---|
| Mean | 30.2 ± 6.6 | 29.9 ± 6.2 | 30.0 ± 6.4 |
| Diabetes(Participants) | Precision Strategy (PS) | Usual Testing (UT) | Total |
|---|---|---|---|
| Count of participants | 176 | 197 | 373 |
| Dyslipidemia(Participants) | Precision Strategy (PS) | Usual Testing (UT) | Total |
|---|---|---|---|
| Count of participants | 668 | 681 | 1349 |
| Family history of premature CAD(Participants) | Precision Strategy (PS) | Usual Testing (UT) | Total |
|---|---|---|---|
| Count of participants | 404 | 395 | 799 |
7 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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HeartFlow, Inc.