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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06376851
Other study ID # CP-910-001
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 27, 2024
Est. completion date March 27, 2030

Study information

Verified date April 2024
Source HeartFlow, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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).


Description:

The DECIDE Registry is a post-market, multi-center, data collection study assessing the change in management of clinically stable, symptomatic 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 10000
Est. completion date March 27, 2030
Est. primary completion date March 27, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria (all must be present) : 1. Groups 1, 2, and 4: 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. All groups: Clinically stable, symptomatic Exclusion Criteria (all must be absent) : 1. ED presentation (at the time of the CCTA) 2. Previous history of CAD (prior to the CCTA) 3. Acute chest pain (in patients who have not been ruled out for ACS) 4. Previously evaluated with and/or in a study which includes AI-QCPA

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
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.

Locations

Country Name City State
United States Moses Cone Memorial Hospital Greensboro North Carolina

Sponsors (1)

Lead Sponsor Collaborator
HeartFlow, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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)
Other Timing of referral to other provider(s) for management 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
Other 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
Other 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
Other 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
Primary 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
Secondary Change in LDL levels across the groups From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Secondary Change in HbA1c levels across the groups From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Secondary 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
Secondary Changes in HDL levels across the groups From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Secondary Changes in TG levels across the groups From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Secondary Changes in weight across the groups From baseline to 90 days, from 90 days to 180 days, and 90 days to 365 days
Secondary Reclassification rate of medical management (across the groups) Change in preventive medical management (lower or intensify). 90 Days, 180 Days and 365 Days
Secondary Rates of referral to invasive coronary angiography and coronary revascularization (PCI+CABG) across the groups 90 Days, 180 Days and 365 Days
Secondary Number of CV hospitalizations across the groups At 365 Days (and potentially out to 5 years)
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