Risk Evaluation With AI-CPA + HCS For Patients IN Whom Calcium is confirmEd to Improve Coronary Artery Disease Care
HeartFlow, Inc.
Summary
REFINE-CAC is a prospective, multi-center trial assessing the management of asymptomatic participants with CAC scores 1-299 Agatston units or incidental CAC findings on chest computed tomography (CT), all of whom will undergo CCTA and are blinded to the coronary anatomy (e.g., % stenosis). The trial includes a randomized, controlled pathway and a single arm, observational registry pathway.
Description
The primary objective of the REFINE-CAC trial is to assess change in lipid lowering therapy over time in asymptomatic participants with coronary artery calcium (CAC) findings who will undergo a blinded coronary computed tomographic angiography (CCTA) and are randomly assigned to either the test arm or the usual care arm.
Eligibility
- Age range
- 40–79 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Calcium score between 1-299 between 3-6 months prior to Day 0 or incidental CAC findings on a chest CT between 3 to 6 months prior to Day 0 2. Men ≥40 and ≤79, Women ≥45 and ≤79 3. Patients who do not have symptoms suggestive of CAD 4. Visible plaque on CCTA 5. No other clinical CCTA subsequent to CAC findings but prior to screening 6. No prior history of atherosclerotic cardiovascular disease (ASCVD) 7. Acceptable CCTA quality per Heartflow acceptance criteria 8. eGFR \>45 mL/min per most recent measurement within 90 days 9. Willingness to comply with all aspects of th…
Interventions
- DeviceHeartflow Analysis
REFINE-CAC will provide Heartflow Analyses
Location
- REFINE-CAC Trial SiteNew York, New York