DECIDE Registry: AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- HeartFlow, Inc.
- Enrollment
- 10000
- Locations
- 1
- Primary Endpoint
- Primary Endpoint
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary Endpoint
Time Frame: 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 Outcomes
- Reclassification rate of symptoms(90 Days, 180 Days and 365 Days)
- Number of CV hospitalizations(At 365 Days (and potentially out to 5 years))
- Number of Revascularizations(365 Days)
- Changes in weight(From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days)
- Reclassification rate of medical management (across the groups)(90 Days, 180 Days and 365 Days)
- Rates of referral to invasive coronary angiography and coronary revascularization (PCI+CABG)(90 Days, 180 Days and 365 Days)
- Changes in Non HDL levels(From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days)
- Changes in HDL levels(From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days)
- Changes in TG levels(From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days)
- Change in LDL levels(From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days)
- Change in HbA1c levels(From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days)