Clinical trial NCT06376851: AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management
Official title: DECIDE Registry: AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Coronary Artery Disease
Keywords: CAD
AI-QCPA
Lead sponsor: HeartFlow, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-19
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Endpoint
timeFrame: 90 Days
Secondary outcomes:
measure: Change in LDL levels
timeFrame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
measure: Change in HbA1c levels
timeFrame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
measure: Changes in Non HDL levels
timeFrame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
measure: Changes in HDL levels
timeFrame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
measure: Changes in TG levels
timeFrame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
measure: Changes in weight
timeFrame: From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
measure: Reclassification rate of medical management (across the groups)
timeFrame: 90 Days, 180 Days and 365 Days
measure: Rates of referral to invasive coronary angiography and coronary revascularization (PCI+CABG)
timeFrame: 90 Days, 180 Days and 365 Days
measure: Reclassification rate of symptoms
timeFrame: 90 Days, 180 Days and 365 Days
measure: Number of CV hospitalizations
timeFrame: At 365 Days (and potentially out to 5 years)
measure: Number of Revascularizations
timeFrame: 365 Days
Other outcomes:
measure: Number of MACE (CV-related death, MI, or CAD hospitalization)
timeFrame: At 365 Days (and potentially out to 5 years)
measure: Timing of referral to other provider(s) for management
timeFrame: Group 1 vs. Group 2 at 90 days post AI-QCPA and Group 2 vs. 4 at 90 days post AI-QCPA
measure: Timing of lab orders (Group 1 vs. Group 2)
timeFrame: Group 1 vs. Group 2 at 90 days post AI-QCPA and Group 2 vs. 4 at 90 days post AI-QCPA
measure: Change in Lp(a) (Group 2)
timeFrame: Baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
measure: Change in Lp(a) (Group 4 compared to Group 1)
timeFrame: Baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
measure: Rate of cardiac testing
timeFrame: At 365 Days (and potentially out to 5 years)
Locations:
city: Greensboro
country: United States
facility: Moses Cone Memorial Hospital
state: North Carolina
Study officials:
affiliation: CAMC Health System
name: Sarah Rinehart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MOUNT SINAI HOSPITAL
name: Leslee Shaw, MD
role: PRINCIPAL_INVESTIGATOR
References: