AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management (DECIDE)

HeartFlow

Status: Invitation-only

Conditions: Coronary Artery Disease

Treatments: Diagnostic Test: AI-enabled quantitative coronary plaque analysis (AI-QCPA)

Study type: Observational

Funder types: Industry

Identifiers

NCT06376851

CP-910-001

Details and patient eligibility

About

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).

Full description

The DECIDE Registry is a post-market, multi-center, data collection study assessing the change in management of clinically stable patients who undergo CCTA with plaque detected. Data will be retrospectively collected following the CCTA, and analyses will be completed 90 days, 180 days, and 1 year after CCTA. Data may be retrospectively collected annually up to 5 years.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

20,000 participants in 6 patient groups

Group 1: No AI-QCPA

Description:

This group includes previously scanned, symptomatic patients with plaque detected and no prior revascularization. No AI-QCPA will be provided.

Group 2: Delayed AI-QCPA

Description:

This group includes previously scanned, symptomatic patients with plaque detected and no prior revascularization. Ninety days following the CCTA, an AI-QCPA report will be provided to the CCTA reader who will in turn provide it to the treating clinician. The treating clinician will decide if changes to medical management are required to effectively treat the patient and if so, treating clinician will contact the patient with the new treatment plan.

Treatment:

Diagnostic Test: AI-enabled quantitative coronary plaque analysis (AI-QCPA)

Group 3: Stress Test Only

Description:

This group includes symptomatic patients who previously had non-invasive stress testing only with no CCTA and no prior revascularization. No AI-QCPA will be provided.

Group 4: Prospective AI-QCPA, symptomatic without prior revascularization

Description:

This group includes newly scanned, symptomatic patients with plaque detected and no prior revascularization. Patients in this group will have current symptoms suggestive of CAD and will not have had prior revascularization. CCTA reader who identifies plaque orders AI-QCPA to inform the medical management plan for the patient.

Treatment:

Diagnostic Test: AI-enabled quantitative coronary plaque analysis (AI-QCPA)

Group 5: Prospective AI-QCPA, prior PCI

Description:

This group includes newly scanned patients with plaque detected. Patients in this group can by symptomatic or asymptomatic and will have had prior PCI in only one vessel territory (CABG patients are not eligible). CCTA reader who identifies plaque orders AI-QCPA to inform the medical management plan for the patient.

Treatment:

Diagnostic Test: AI-enabled quantitative coronary plaque analysis (AI-QCPA)

Group 6: Prospective AI-QCPA, asymptomatic without prior revascularization

Description:

This group includes newly scanned, asymptomatic patients with plaque detected and no prior revascularization. Patients in this group will not have current symptoms suggestive of CAD and will not have had prior revascularization. CCTA reader who identifies plaque orders AI-QCPA to inform the medical management plan for the patient.

Treatment:

Diagnostic Test: AI-enabled quantitative coronary plaque analysis (AI-QCPA)