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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Group 5: Prospective AI-QCPA, prior PCI |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria (all must be present) :
Exclusion Criteria (all must be absent) :
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Rinehart, MD | CAMC Health System | Principal Investigator |
| Leslee Shaw, MD | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moses Cone Memorial Hospital | Greensboro | North Carolina | 27401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41817483 | Derived | 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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. |
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| 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. |
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| 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 |
| Reclassification rate of symptoms | Improvement in symptoms 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) |
| Number of Revascularizations | At one year across the groups | 365 Days |
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) |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |