NCT07834372Not yet recruiting
REWRITE-CAD Protocol: Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease
Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
REWRITE-CAD is a prospective, randomized, multi-center trial assessing the management of asymptomatic participants with a history of PCI or MI who will undergo a blinded CCTA and be randomly assigned to either the test arm in which participants receive the unblinded results of Heartflow AI-CPA or the usual care arm in which participants are blinded to the AI-CPA results.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- First submitted
- 11 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Oct 2027
- Lead sponsor
- HeartFlow, Inc.
- Diseases
- Coronary artery disease
- NCT number
- NCT07834372
What you commit to
- Study type: Interventional
- Planned participants: 350
- From Oct 2026 to the primary completion date, Oct 2027
- 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
- Prior coronary artery bypass graft (CABG)
- Prior stents in 2+ vessel territories
- Previously evaluated with and/or in a trial which includes AI-CPA
- Active chemotherapy and/or radiation
- Imaging Based (all to be assessed by CCTA core lab)
Other illness
- Symptoms suggestive of CAD (e.g. stable angina or dyspnea on exertion)
- 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
- Incidental findings requiring immediate follow-up or management (e.g., Aortic dissection, findings suggestive of cancer, pulmonary embolism)
Lab values
- Reduced left ventricular ejection fraction (LVEF) \<35%, if known
- LDL-C \<70 mg/dL at baseline lab draw
Other
- Non-imaging based
- On PCSK9i and/or inclisiran at baseline
- Life expectancy less than 2 years due to non-CV comorbidities
- Left Main (LM) ≥50% stenosis on baseline CCTA
- Proximal LAD FFRct \<0.75
- Total occlusions in major vessels and/or total occlusion in stent
- No visible plaque in non-stented segments on CCTA
- Findings that require further imaging follow-up within 1 year (e.g., pulmonary nodules ≥6 mm)
Who the study is looking for
- History of PCI (1 year - 5 years prior to Day 0) and/or history of MI (Type I or II) (1 year - 5 years prior to Day 0)
- Patients who do not exhibit symptoms suggestive of CAD
- No other clinical CCTA subsequent to MI/PCI but prior to screening
- 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 a female participant 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
- Visible plaque in non-stented region on CCTA as assessed by CCTA core lab
- Acceptable CCTA quality per Heartflow acceptance criteria
Age in the registry: 18 years to - · 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 | Greensboro | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.