Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- HeartFlow, Inc.
- Enrollment
- 2103
- Locations
- 1
- Primary Endpoint
- Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease
Time Frame: 1 year
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.
Secondary Outcomes
- Number of Unplanned Hospitalizations (Including Admissions With Death or MI)(1 year)
- Number of Participants With Quality of Life (Angina Frequency) Assessment(1 year)
- Cumulative Radiation Exposure From All Cardiovascular Procedures (12 M), MilliSievert (mSv)(1 year)
- Number of Participants With Preventive Medication Use(1 Year)
- Number of Catheterization and Revascularization Procedures(1 year)