REFINE-CAC Protocol: Risk Evaluation With AI-CPA + HCS For Patients IN Whom Calcium is confirmEd to Improve Coronary Artery Disease Care

NCT07853716 | Not Yet Recruiting FDA Device

• 1 other identifier: CP-913-001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CAD - Coronary Artery Disease

Keywords

CAD; AI-CPA; CCTA; CACS; CAC; Coronary Plaque; Incidental CAC

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who initiate, intensify, cease, or de-escalate lipid lowering therapy (LLT)

  Enrollment to 90 days

Secondary Outcomes (8)

• Percentage of participants who initiate, intensify, cease, or de-escalate lipid-lowering therapy (LLT)

  Enrollment through end of study at 21 months

• Percentage of participants who initiate, intensify, cease, or de-escalate medication therapy

  Enrollment through end of study at 21 months

• Time to initiation, intensification, cessation, or de-escalation of LLT

  Enrollment through end of study at 21 months

• Percent of participants undergoing lipid testing

  Enrollment through end of study at 21 months

• LDL-C changes

  Enrollment through end of study at 21 months

Study Arms (3)

Usual Care Arm

NO INTERVENTION

Unblinded Test Arm

EXPERIMENTAL

Device: Heartflow Analysis

Unblinded Registry Arm

OTHER

Device: Heartflow Analysis

Interventions

Heartflow Analysis DEVICE

REFINE-CAC will provide Heartflow Analyses

Unblinded Registry Arm; Unblinded Test Arm

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Symptoms suggestive of CAD (e.g. stable angina)
• On PCSK9 targeted therapy (e.g. evolocumab, alirocumab, inclisiran, or enlicitide)
• Reduced left ventricular ejection fraction (LVEF) \<35%, if known
• Prior history of ASCVD
• Prior coronary artery bypass graft (CABG)
• Prior percutaneous coronary intervention (PCI)
• Life expectancy less than 2 years due to non-CV comorbidities
• Enrolled in an investigational trial that involves a non-approved cardiac drug or device
• Previously evaluated with and/or in a trial which includes AI-CPA
• Any condition that might interfere with trial procedures or follow up visits
• LDL-C \<70 mg/dL at baseline lab draw
• Active chemotherapy and/or radiation

Sponsors & Collaborators

• HeartFlow, Inc.: lead
• Avania: collaborator

Study Sites (1)

REFINE-CAC Trial Site

New York, New York, 10005, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Whitney Huey

CONTACT

8774783569; whuey@heartflow.com

Blair Holman

CONTACT

8774783569; bholman@heartflow.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized using a 1:1 randomization scheme via an interactive web or voice-based system (IXRS). Randomization will occur into one of two arms: the test arm, in which participants will undergo CCTA blinded to coronary anatomy and receive unblinded Heartflow Analyses, or the usual care arm, in which participants will undergo a blinded CCTA with blinded Heartflow Analyses.

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)