AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management
DECIDE
DECIDE Registry: AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management
1 other identifier
observational
20,000
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2024
CompletedFirst Submitted
Initial submission to the registry
March 28, 2024
CompletedFirst Posted
Study publicly available on registry
April 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2030
ExpectedOctober 14, 2025
October 1, 2025
2 years
March 28, 2024
October 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Endpoint
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.
90 Days
Secondary Outcomes (11)
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
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
- +6 more secondary outcomes
Other Outcomes (6)
Number of MACE (CV-related death, MI, or CAD hospitalization)
At 365 Days (and potentially out to 5 years)
Timing of referral to other provider(s) for management
Group 1 vs. Group 2 at 90 days post AI-QCPA and Group 2 vs. 4 at 90 days post AI-QCPA
Timing of lab orders (Group 1 vs. Group 2)
Group 1 vs. Group 2 at 90 days post AI-QCPA and Group 2 vs. 4 at 90 days post AI-QCPA
- +3 more other outcomes
Study Arms (6)
Group 1: No AI-QCPA
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
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 3: Stress Test Only
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
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
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
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.
Interventions
The HeartFlow Plaque Analysis provides plaque identification, quantification, and characterization and is meant to support qualified clinicians to aid in the evaluation and risk assessment of coronary artery disease (CAD). It provides data on the volume and type of plaque present (Calcified, Non-calcified, Low Attenuation), both vessel specific and total volumes, with which physicians can better understand a patient's risk, discuss heart health, and help optimize medical management. Plaque Analysis is calculated using image data from a previously acquired CCTA.
Eligibility Criteria
Deidentified data will be collected for all patients who have had a CCTA with plaque detected or a stress test and are included by the site in the registry.
You may qualify if:
- Groups 1, 2,4,5 and 6: CCTA and plaque detected
- 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
- Groups 1,2,3 and 4: Clinically stable, symptomatic
- Group 6: Clinically stable without symptoms suggestive of CAD at the time of the CCTA
You may not qualify if:
- ED presentation (at the time of the CCTA or stress test)
- Groups 1,2,3,4, and 6: Previous history of CAD (prior to the CCTA or stress test with history of revascularization)
- 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
- Acute chest pain (in patients who have not been ruled out for ACS)
- Previously evaluated with and/or in a study which includes AI-QCPA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HeartFlow, Inc.lead
Study Sites (1)
Moses Cone Memorial Hospital
Greensboro, North Carolina, 27401, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah Rinehart, MD
CAMC Health System
- PRINCIPAL INVESTIGATOR
Leslee Shaw, MD
MOUNT SINAI HOSPITAL
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2024
First Posted
April 19, 2024
Study Start
March 27, 2024
Primary Completion
March 27, 2026
Study Completion (Estimated)
March 27, 2030
Last Updated
October 14, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share