Heartflow analysis to guide care for people with calcium in heart arteries
Tests Heartflow Analysis in adults with coronary artery disease and no symptoms.
Plain-language title generated from the registry record
Registry title: REFINE-CAC Protocol: Risk Evaluation With AI-CPA + HCS For Patients IN Whom Calcium is confirmEd to Improve Coronary Artery Disease Care
Key facts
- Where
- New York, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 79 years old?
Source: NCT07853716, who can take part
Where in United States
- New YorkNew York, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- HeartFlow, Inc.
- Trial code
- NCT07853716
- Record updated
- 2 October 2026
- Original description
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.Read full original descriptionShow less
Risk Evaluation With AI-CPA + HCS For Patients IN Whom Calcium is confirmEd to Improve Coronary Artery Disease Care
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.
Inclusion: 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; Men ≥40 and ≤79, Women ≥45 and ≤79; Patients who do not have symptoms suggestive of CAD; Visible plaque on CCTA; No other clinical CCTA subsequent to CAC findings but prior to screening; No prior history of atherosclerotic cardiovascular disease (ASCVD); Acceptable CCTA quality per Heartflow acceptance criteria; eGFR >45 mL/min per most recent measurement within 90 days; 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; 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; Ability to provide informed consent.
Exclusion: On PCSK9 targeted therapy (e.g. evolocumab, alirocumab, inclisiran, or enlicitide); Prior history of ASCVD; Prior coronary artery bypass graft (CABG); Prior percutaneous coronary intervention (PCI); Previously evaluated with and/or in a trial which includes AI-CPA; Active chemotherapy and/or radiation; Symptoms suggestive of CAD (e.g. stable angina); Enrolled in an investigational trial that involves a non-approved cardiac drug or device; Any condition that might interfere with trial procedures or follow up visits; Reduced left ventricular ejection fraction (LVEF) <35%, if known; LDL-C <70 mg/dL at baseline lab draw; Life expectancy less than 2 years due to non-CV comorbidities.