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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: AI-enabled 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 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 Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Moses Cone Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: AI-enabled quantitative coronary plaque analysis (AI-QCPA); 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.
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.	Diagnostic test: AI-enabled quantitative coronary plaque analysis (AI-QCPA); 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.
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.	Diagnostic test: AI-enabled quantitative coronary plaque analysis (AI-QCPA); 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.
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.	Diagnostic test: AI-enabled quantitative coronary plaque analysis (AI-QCPA); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of MACE (CV-related death, MI, or CAD hospitalization)	Exploratory & safety endpoints will be compared across the groups unless otherwise noted	At 365 Days (and potentially out to 5 years)
Timing of referral to other provider(s) for management	across the groups unless otherwise noted	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)	across the groups unless otherwise noted	Group 1 vs. Group 2 at 90 days post AI-QCPA and Group 2 vs. 4 at 90 days post AI-QCPA
Change in Lp(a) (Group 2)	across the groups unless otherwise noted	Baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Change in Lp(a) (Group 4 compared to Group 1)	across the groups unless otherwise noted	Baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Rate of cardiac testing	Efficiency of testing based upon imaging and reports for all other cardiac tests including CCTA, SPECT, echo, CAC, and stress echo	At 365 Days (and potentially out to 5 years)

Collaborators and Investigators

• Sponsor: HeartFlow, Inc.
• Investigators: Principal Investigator: Sarah Rinehart, MD, CAMC Health System; Principal Investigator: Leslee Shaw, MD, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2024
• Primary Completion (Estimated): March 27, 2026
• Study Completion (Estimated): March 27, 2030

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 9, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: CAD; AI-QCPA
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: CP-910-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No