Coronary Artery Disease
Conditions
Keywords
CAD, AI-QCPA
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).
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.
Interventions
DIAGNOSTIC_TESTAI-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.
Sponsors
HeartFlow, Inc.
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in LDL levels | From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days | across the groups |
| Change in HbA1c levels | From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days | across the groups |
| Changes in Non HDL levels | From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days | across the groups |
| Changes in HDL levels | From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days | across the groups |
| Changes in TG levels | From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days | across the groups |
| Changes in weight | From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days | across the groups |
| Reclassification rate of medical management (across the groups) | 90 Days, 180 Days and 365 Days | Change in preventive medical management (lower or intensify). |
| Rates of referral to invasive coronary angiography and coronary revascularization (PCI+CABG) | 90 Days, 180 Days and 365 Days | across the groups |
| Reclassification rate of symptoms | 90 Days, 180 Days and 365 Days | Improvement in symptoms across the groups |
| Number of CV hospitalizations | At 365 Days (and potentially out to 5 years) | across the groups |
| Number of Revascularizations | 365 Days | At one year across the groups |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah Rinehart, MD
CAMC Health System
PRINCIPAL_INVESTIGATORLeslee Shaw, MD
MOUNT SINAI HOSPITAL
Outcome results
None listed