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NCT Number: NCT06376851

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Moses Cone Memorial Hospital

Greensboro, North Carolina, 27401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(all must be present) :

  • 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

Exclusion criteria

(all must be absent) :

  • 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

Treatment and study plan

AI-enabled quantitative coronary plaque analysis (AI-QCPA)

Diagnostic Test

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.

Primary outcomes

  1. 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

  1. Change in LDL levels

    Time frame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days

    across the groups

  2. Change in HbA1c levels

    Time frame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days

    across the groups

  3. Changes in Non HDL levels

    Time frame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days

    across the groups

  4. Changes in HDL levels

    Time frame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days

    across the groups

  5. Changes in TG levels

    Time frame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days

    across the groups

  6. Changes in weight

    Time frame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days

    across the groups

  7. Reclassification rate of medical management (across the groups)

    Time frame: 90 Days, 180 Days and 365 Days

    Change in preventive medical management (lower or intensify).

  8. Rates of referral to invasive coronary angiography and coronary revascularization (PCI+CABG)

    Time frame: 90 Days, 180 Days and 365 Days

    across the groups

  9. Reclassification rate of symptoms

    Time frame: 90 Days, 180 Days and 365 Days

    Improvement in symptoms across the groups

  10. Number of CV hospitalizations

    Time frame: At 365 Days (and potentially out to 5 years)

    across the groups

  11. Number of Revascularizations

    Time frame: 365 Days

    At one year across the groups

Other outcomes

  1. Number of MACE (CV-related death, MI, or CAD hospitalization)

    Time frame: At 365 Days (and potentially out to 5 years)

    Exploratory & safety endpoints will be compared across the groups unless otherwise noted

  2. Timing of referral to other provider(s) for management

    Time frame: Group 1 vs. Group 2 at 90 days post AI-QCPA and Group 2 vs. 4 at 90 days post AI-QCPA

    across the groups unless otherwise noted

  3. Timing of lab orders (Group 1 vs. Group 2)

    Time frame: Group 1 vs. Group 2 at 90 days post AI-QCPA and Group 2 vs. 4 at 90 days post AI-QCPA

    across the groups unless otherwise noted

  4. Change in Lp(a) (Group 2)

    Time frame: Baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days

    across the groups unless otherwise noted

  5. Change in Lp(a) (Group 4 compared to Group 1)

    Time frame: Baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days

    across the groups unless otherwise noted

  6. Rate of cardiac testing

    Time frame: At 365 Days (and potentially out to 5 years)

    Efficiency of testing based upon imaging and reports for all other cardiac tests including CCTA, SPECT, echo, CAC, and stress echo

Sponsors and collaborators

Lead sponsor

HeartFlow, Inc.

Industry

Registry information

Official study title

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

Acronym: DECIDE

Important dates

Study start
2024
Primary completion
2026
Study completion
2030
First posted
Apr 19, 2024
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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