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

• Conditions: Coronary Artery Disease

• 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

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
Rates of referral to invasive coronary angiography and coronary revascularization (PCI+CABG)	90 Days, 180 Days and 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
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).
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

Trial Locations

Locations (1)

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