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Active Not Recruiting
NCT06376851
AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management
Conditions: Coronary Artery Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 20000
Sponsor: HeartFlow, Inc.
Location: Moses Cone Memorial Hospital Greensboro North Carolina
Summary
The objective of HeartFlow's DECIDE Registry is to collect observational data about the management of patients before and after HeartFlow Artificial Intelligence-Quantitative Coronary Plaque Analysis (AI-QCPA).
Eligibility Criteria
Inclusion Criteria (all must be present) :
1. Groups 1, 2,4,5 and 6: CCTA and plaque detected
2. Group 3: Any patient with a stress test (stress echocardiogram or nuclear imaging including SPECT or PET) and no CCTA within the 90 days prior to site activation
3. Groups 1,2,3 and 4: Clinically stable, symptomatic
4. Group 6: Clinically stable without symptoms suggestive of CAD at the time of the CCTA
Exclusion Criteria (all must be absent) :
1. ED presentation (at the time of the CCTA or stress test)
2. Groups 1,2,3,4, and 6: Previous history of CAD (prior to the CCTA or stress test with history of revascularization)
3. Group 5: Prior history of PCI in multiple vessel territories, PCI in the Left Main, CABG, and/or any other conditions or limitations which would prevent successful CCTA processing by HeartFlow
4. Acute chest pain (in patients who have not been ruled out for ACS)
5. Previously evaluated with and/or in a study which includes AI-QCPA
Source: ClinicalTrials.gov (NCT06376851). StuddyBuddy aggregates publicly available trial information.