REWRITE-CAD Protocol: Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease
Part of paid clinical trials in Greensboro, North Carolina.
- Sponsor
- HeartFlow, Inc.
- Study ID
- NCT07834372
- Status
- Not Yet Recruiting
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Conditions
- CAD - Coronary Artery Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Heartflow Analysis — DEVICEREWRITE-CAD will provide AI-CPA results
Study Details
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.
Key Dates
- First listed
- Sep 22, 2026
- Start date
- Oct 31, 2026
- Status verified
- Sep 2026
- Primary completion
- Oct 31, 2027
- Completion
- Apr 30, 2029
Study Design
- Enrollment
- 350 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- No Intervention: Usual Care Arm
- Experimental: Unblinded AI-CPA Test Arm
Primary Outcome Measure
Percentage of participants who initiate or intensify lipid-lowering therapy (LLT) [ Time Frame: Enrollment to 90 days ]
Central Contacts
- Whitney Huey877-478-3569
- Zachary Sterner, Ph.D877-478-3569
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| REWRITE-CAD Trial Site | Greensboro | North Carolina | 27401 |