Coronary Artery DiseaseDECIDENCT06376851

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

An observational study of Coronary Artery Disease, run by HeartFlow, Inc. at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: AI-enabled quantitative coronary plaque analysis (AI-QCPA)
How many people: 20,000 participants
Where: 1 siteUnited States
Study dates: 27 Mar 2024to 27 Mar 2030
How long will I take part?: 5 Years
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Moses Cone Memorial Hospital
Greensboro, North Carolina, 27401

Other trials in United States

About this study

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

Read the 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.

Conditions: Coronary Artery Disease
Being tested: AI-enabled quantitative coronary plaque analysis (AI-QCPA)
Keywords: CAD, AI-QCPA
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT06376851
Study group	Role	What they receive
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. Receives: Diagnostic Test: AI-enabled quantitative coronary plaque analysis (AI-QCPA)
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. Receives: Diagnostic Test: AI-enabled quantitative coronary plaque analysis (AI-QCPA)
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. Receives: Diagnostic Test: AI-enabled quantitative coronary plaque analysis (AI-QCPA)
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. Receives: Diagnostic Test: AI-enabled quantitative coronary plaque analysis (AI-QCPA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 90 Days

Secondary outcomes (11)

Change in LDL levels
across the groups
Measured: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Change in HbA1c levels
across the groups
Measured: 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
Measured: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Changes in HDL levels
across the groups
Measured: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Changes in TG levels
across the groups
Measured: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Changes in weight
across the groups
Measured: 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).
Measured: 90 Days, 180 Days and 365 Days
Rates of referral to invasive coronary angiography and coronary revascularization (PCI+CABG)
across the groups
Measured: 90 Days, 180 Days and 365 Days
Reclassification rate of symptoms
Improvement in symptoms across the groups
Measured: 90 Days, 180 Days and 365 Days
Number of CV hospitalizations
across the groups
Measured: At 365 Days (and potentially out to 5 years)
Number of Revascularizations
At one year across the groups
Measured: 365 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 202427 Mar 2030

First posted19 Apr 2024
Study start27 Mar 2024
Primary completion27 Mar 2026
Study completion27 Mar 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 20,000 participants (estimated)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT06376851
Sponsor's protocol ID: CP-910-001
Acronym: DECIDE
Status last verified: Oct 2025
First submitted: 28 Mar 2024
Last updated: 15 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Rinehart S, Blankstein R, McCarthy CP, Januzzi JL, Scherer M, O'Neal WT, Green P, Puma J, Corrigan F, Datta J, Eichhorn J, Stuckey T, Khalique O, Ali Z, Ng N, Huey W, Mullen S, Rogers C, Shaw LJ; DECIDE Investigators. Guiding Preventive Care Strategies for Patients With Atherosclerotic Plaque on Coronary CTA: Primary Outcomes of the DECIDE Registry. JACC Cardiovasc Imaging. 2026 Jun;19(6):706-716. doi: 10.1016/j.jcmg.2026.01.014. Epub 2026 Mar 12.
PubMed 41817483

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DECIDE Registry: AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management
ClinicalTrials.gov ID: NCT06376851
Acronym / sponsor ID: DECIDE / CP-910-001
Conditions: Coronary Artery Disease
Keywords: CAD, AI-QCPA
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 20,000 participants (estimated)
Lead sponsor: HeartFlow, Inc.Industry (pharma, biotech, devices)
Study start: 27 Mar 2024 (actual)
Primary completion: 27 Mar 2026 (actual)
Study completion: 27 Mar 2030 (estimated)
First posted: 19 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Target follow-up: 5 Years
Number of arms: 6

Arm	Type	Receives
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	–	Diagnostic Test: AI-enabled quantitative coronary plaque analysis (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	–	Diagnostic Test: AI-enabled quantitative coronary plaque analysis (AI-QCPA)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	–	Diagnostic Test: AI-enabled quantitative coronary plaque analysis (AI-QCPA)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	–	Diagnostic Test: AI-enabled quantitative coronary plaque analysis (AI-QCPA)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Diagnostic test	Group 2: Delayed AI-QCPA, Group 4: Prospective AI-QCPA, symptomatic without prior revascularization, Group 5: Prospective AI-QCPA, prior PCI, Group 6: Prospective AI-QCPA, asymptomatic without prior revascularization

Primary outcome

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.

11 secondary outcomes

Change in LDL levels
Time frame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Change in HbA1c levels
Time frame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Changes in Non HDL levels
Time frame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Changes in HDL levels
Time frame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Changes in TG levels
Time frame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Changes in weight
Time frame: 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)
Time frame: 90 Days, 180 Days and 365 Days
Rates of referral to invasive coronary angiography and coronary revascularization (PCI+CABG)
Time frame: 90 Days, 180 Days and 365 Days
Reclassification rate of symptoms
Time frame: 90 Days, 180 Days and 365 Days
Number of CV hospitalizations
Time frame: At 365 Days (and potentially out to 5 years)
Number of Revascularizations
Time frame: 365 Days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
Derived from this study: PubMed 41817483Rinehart S, Blankstein R, McCarthy CP, Januzzi JL, Scherer M, O'Neal WT, Green P, Puma J, Corrigan F, Datta J, Eichhorn J, Stuckey T, Khalique O, Ali Z, Ng N, Huey W, Mullen S, Rogers C, Shaw LJ; DECIDE Investigators. Guiding Preventive Care Strategies for Patients With Atherosclerotic Plaque on Coronary CTA: Primary Outcomes of the DECIDE Registry. JACC Cardiovasc Imaging. 2026 Jun;19(6):706-716. doi: 10.1016/j.jcmg.2026.01.014. Epub 2026 Mar 12.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sarah Rinehart, MD principal investigator

CAMC Health System

Leslee Shaw, MD principal investigator

MOUNT SINAI HOSPITAL

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by HeartFlow, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint (time frame: 90 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06376851, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.