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.
Study Type
OBSERVATIONAL
Enrollment
20,000
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.
Moses Cone Memorial Hospital
Greensboro, North Carolina, United States
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.
Time frame: 90 Days
Change in LDL levels
across the groups
Time frame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Change in HbA1c levels
across the groups
Time frame: 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
Time frame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Changes in HDL levels
across the groups
Time frame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Changes in TG levels
across the groups
Time frame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Changes in weight
across the groups
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)
Change in preventive medical management (lower or intensify).
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Time frame: 90 Days, 180 Days and 365 Days
Rates of referral to invasive coronary angiography and coronary revascularization (PCI+CABG)
across the groups
Time frame: 90 Days, 180 Days and 365 Days
Reclassification rate of symptoms
Improvement in symptoms across the groups
Time frame: 90 Days, 180 Days and 365 Days
Number of CV hospitalizations
across the groups
Time frame: At 365 Days (and potentially out to 5 years)
Number of Revascularizations
At one year across the groups
Time frame: 365 Days