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REFINE-CAC Protocol: Risk Evaluation With AI-CPA + HCS For Patients IN Whom Calcium is confirmEd to Improve Coronary Artery Disease Care
Condition(s) studied
CAD - Coronary Artery Disease
Investigational drug(s) / intervention(s)
Heartflow Analysis
Heartflow Analysis: REFINE-CAC will provide Heartflow Analyses
Study 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.
Eligibility
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 the protocol including research CCTAs, lab draws, medication adherence assessments, attending all study visits, and the ability to comply with prescribed medications
10. For participants of childbearing potential (those who have not been surgically sterilized), a pregnancy test must be performed with negative results known within 7 days prior to randomization
11. Ability to provide informed consent
Exclusion Criteria:
1. Symptoms suggestive of CAD (e.g. stable angina)
2. On PCSK9 targeted therapy (e.g. evolocumab, alirocumab, inclisiran, or enlicitide)
3. Reduced left ventricular ejection fraction (LVEF) \<35%, if known
4. Prior history of ASCVD
5. Prior coronary artery bypass graft (CABG)
6. Prior percutaneous coronary intervention (PCI)
7. Life expectancy less than 2 years due to non-CV comorbidities
8. Enrolled in an investigational trial that involves a non-approved cardiac drug or device
9. Previously evaluated with and/or in a trial which includes AI-CPA
10. Any condition that might interfere with trial procedures or follow up visits
11. LDL-C \<70 mg/dL at baseline lab draw
12. Active chemotherapy and/or radiation
Primary outcome measure(s)
- Percentage of participants who initiate, intensify, cease, or de-escalate lipid lowering therapy (LLT) — Enrollment to 90 days
Trial sites (1)
| Facility | City | Region | Status |
| REFINE-CAC Trial Site |
New York |
New York |
|
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