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

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: AI-enabled quantitative coronary plaque analysis (AI-QCPA)

• Registration Number: NCT06376851
• Lead Sponsor: HeartFlow, Inc.

Brief 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).

Detailed Description

The DECIDE Registry is a post-market, multi-center, data collection study assessing the change in management of clinically stable, symptomatic 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.

Study Timeline

• Study Start: 2024-03-27
• Study First Submitted: 2024-03-28
• Study First Submitted QC: 2024-04-17
• Study First Posted: 2024-04-19
• Status Verified: 2024-09
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2026-03-27
• Study Completion: 2030-03-27

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2: Delayed AI-QCPA	AI-enabled quantitative coronary plaque analysis (AI-QCPA)	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.
Group 4: Prospective AI-QCPA, symptomatic without prior revascularization	AI-enabled quantitative coronary plaque analysis (AI-QCPA)	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.
Group 5: Prospective AI-QCPA, prior PCI	AI-enabled quantitative coronary plaque analysis (AI-QCPA)	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.
Group 6: Prospective AI-QCPA, asymptomatic without prior revascularization	AI-enabled quantitative coronary plaque analysis (AI-QCPA)	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.

Primary Outcome Measures

Name	Time	Method
Primary Endpoint	90 Days	The primary endpoint of the DECIDE Registry is the change in medical management following HeartFlow AI-QCPA at 90 days compared to medical management following CCTA alone. The primary endpoint will only be assessed in patients in Group 2.

Secondary Outcome Measures

Name	Time	Method
Reclassification rate of symptoms	90 Days, 180 Days and 365 Days	Improvement in symptoms across the groups
Number of CV hospitalizations	At 365 Days (and potentially out to 5 years)	across the groups
Number of Revascularizations	365 Days	At one year across the groups
Changes in weight	From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days	across the groups
Reclassification rate of medical management (across the groups)	90 Days, 180 Days and 365 Days	Change in preventive medical management (lower or intensify).
Rates of referral to invasive coronary angiography and coronary revascularization (PCI+CABG)	90 Days, 180 Days and 365 Days	across the groups
Changes in Non HDL levels	From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days	across the groups
Changes in HDL levels	From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days	across the groups
Changes in TG levels	From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days	across the groups
Change in LDL levels	From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days	across the groups
Change in HbA1c levels	From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days	across the groups

Trial Locations

Locations (1)

Moses Cone Memorial Hospital; 🇺🇸 Greensboro, North Carolina, United States