AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management

Coronary Artery Disease Clinical Trial

— DECIDE  

Official title:

DECIDE Registry: AI DErived Plaque Quantification: CCTA and AI-QCPA for Determining Effective CAD Management

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06376851
• Other study ID #: CP-910-001
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease

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)