CAD - Coronary Artery DiseaseREFINE-CACNCT07853716
REFINE-CAC Protocol: Risk Evaluation With AI-CPA + HCS For Patients IN Whom Calcium is confirmEd to Improve Coronary Artery Disease Care
A study testing Heartflow Analysis in people with CAD - Coronary Artery Disease, run by HeartFlow, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- CAD - Coronary Artery Disease
- What is being tested?
- Heartflow Analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
REFINE-CAC Trial Site
New York, New York, 10005
Heartflow Investigator, 8774783569, refine-cac@heartflow.com
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- CAD - Coronary Artery Disease
- Being tested
- Heartflow Analysis
- Keywords
- CAD, AI-CPA, CCTA, CACS, CAC, Coronary Plaque, Incidental CAC
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heartflow AnalysisDevice
REFINE-CAC will provide Heartflow Analyses
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Arm | No intervention | Not described |
| Unblinded Test Arm | Experimental | Not described Receives: Device: Heartflow Analysis |
| Unblinded Registry Arm | Other | Not described Receives: Device: Heartflow Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who initiate, intensify, cease, or de-escalate lipid lowering therapy (LLT)
Measured: Enrollment to 90 days
Secondary outcomes (8)
Percentage of participants who initiate, intensify, cease, or de-escalate lipid-lowering therapy (LLT)
Measured: Enrollment through end of study at 21 months
Percentage of participants who initiate, intensify, cease, or de-escalate medication therapy
Measured: Enrollment through end of study at 21 months
Time to initiation, intensification, cessation, or de-escalation of LLT
Measured: Enrollment through end of study at 21 months
Percent of participants undergoing lipid testing
Measured: Enrollment through end of study at 21 months
LDL-C changes
Measured: Enrollment through end of study at 21 months
Changes in Plaque Volumes
Measured: Enrollment through end of study at 21 months
Rates of referral to invasive coronary angiography and coronary revascularization
Measured: Enrollment through end of study at 21 months
Percentage of participants classified as high adherence on the 8-item Morisky Medication Adherence Scale (MMAS-8)
Evaluated using the 8-item MMAS-8 questionnaire. Total scores range from 0 to 8, where higher scores indicate better adherence. High adherence is defined as achieving a score of 8, medium adherence as 6 to <8, and low adherence as <6.
Measured: Enrollment through end of study at 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAD - Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HeartFlow, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853716
- Sponsor's protocol ID
- CP-913-001
- Acronym
- REFINE-CAC
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Evaluation With AI-CPA + HCS For Patients IN Whom Calcium is confirmEd to Improve Coronary Artery Disease Care
- ClinicalTrials.gov ID
- NCT07853716
- Acronym / sponsor ID
- REFINE-CAC / CP-913-001
- Conditions
- CAD - Coronary Artery Disease
- Keywords
- CAD, AI-CPA, CCTA, CACS, CAC, Coronary Plaque, Incidental CAC
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- HeartFlow, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 2 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care Arm | No intervention | – |
| Unblinded Test Arm | Experimental | Device: Heartflow Analysis |
| Unblinded Registry Arm | Other | Device: Heartflow Analysis |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heartflow AnalysisREFINE-CAC will provide Heartflow Analyses | Device | Unblinded Registry Arm, Unblinded Test Arm |
Primary outcome
Percentage of participants who initiate, intensify, cease, or de-escalate lipid lowering therapy (LLT)
Time frame: Enrollment to 90 days
8 secondary outcomes
Percentage of participants who initiate, intensify, cease, or de-escalate lipid-lowering therapy (LLT)
Time frame: Enrollment through end of study at 21 months
Percentage of participants who initiate, intensify, cease, or de-escalate medication therapy
Time frame: Enrollment through end of study at 21 months
Time to initiation, intensification, cessation, or de-escalation of LLT
Time frame: Enrollment through end of study at 21 months
Percent of participants undergoing lipid testing
Time frame: Enrollment through end of study at 21 months
LDL-C changes
Time frame: Enrollment through end of study at 21 months
Changes in Plaque Volumes
Time frame: Enrollment through end of study at 21 months
Rates of referral to invasive coronary angiography and coronary revascularization
Time frame: Enrollment through end of study at 21 months
Percentage of participants classified as high adherence on the 8-item Morisky Medication Adherence Scale (MMAS-8)
Time frame: Enrollment through end of study at 21 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heartflow Analysis in people with CAD - Coronary Artery Disease, run by HeartFlow, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Whitney Huey (8774783569, whuey@heartflow.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who initiate, intensify, cease, or de-escalate lipid lowering therapy (LLT) (time frame: Enrollment to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.