NCT07853716Not yet recruiting
REFINE-CAC Protocol: Risk Evaluation With AI-CPA + HCS For Patients IN Whom Calcium is confirmEd to Improve Coronary Artery Disease Care
Risk Evaluation With AI-CPA + HCS For Patients IN Whom Calcium is confirmEd to Improve Coronary Artery Disease Care
Source: ClinicalTrials.gov · Last updated 2 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 17 Sept 2026
- Start date
- Nov 2026
- Primary completion date
- Jun 2029
- Lead sponsor
- HeartFlow, Inc.
- Diseases
- Coronary artery disease
- NCT number
- NCT07853716
What you commit to
- Study type: Interventional
- Planned participants: 500
- From Nov 2026 to the primary completion date, Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Reduced left ventricular ejection fraction (LVEF) \<35%, if known
- LDL-C \<70 mg/dL at baseline lab draw
Other
- Life expectancy less than 2 years due to non-CV comorbidities
Who the study is looking for
- 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
Age in the registry: 40 years to 79 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.