Automatic Anatomical and Functional Classification of Coronary Arteries With Artificial Intelligence.

NCT05810610 | Unknown

• 1 other identifier: IMAG-01-2022
• Study Type: observational
• Target: 1,670
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this Category 3 research involving the human person is to predict the measurement of the post-stenosis flow (FFR) using CTTA coupled with an intelligent predictive analysis system and comparing it with invasive coronary angiography FFR as measurement of reference. The population studied are adult patients,- with no diagnosed coronary status or history of stenting or bypass surgery- with indication for FFR measurement. The main question it aims to answer is: • Can, in a single acquisition, CTTA coupled with AI produce good predictive performance of stenosis and FFR ? If it can it will allow us to avoid the need for invasive FFR. For patients who will be included in the retrospective part: only their data from their medical records will be used. Patients who will be included in the prospective part will additionally complete the EQ5D5L questionnaire before coronary angiography and at the end of the patient's participation (4 months after the CCTA). There is a no comparison group, the predictive FFR from CTTA of a patient will be compared with angiography FFR from the same patient, same vessel.

Conditions

Coronary Stenosis

Keywords

Coronary stenosis; CCTA; AI; FFR

Outcome Measures

Primary Outcomes (1)

• Predictive performance, at the coronary vessel level, of an intelligent Coronary CT AI based image analysis system on the detection of a stenosis requiring intervention, versus invasive coronary angiography with reference measurement (FFR).

  This criterion is calculated on the validation sample. Sensitivity at the vessel level will be calculated as the ratio of the number of stenotic vessels classified as interventional by the AI system to the total number of stenotic vessels classified as interventional by the reference method. The other metrics (specificity, likelihood ratios, prevalence and predictive errors) will be calculated, all with their 95% confidence intervals.

  2 years

Secondary Outcomes (1)

• Predictive performance regarding the indication for intervention at the patient level and medico-economic analysis of the cost-effectiveness type comparing two diagnostic strategies strategies (CCTA+AI, vs. usual care = CCTA + invasive FFR)

  2 years

Study Arms (1)

Adult with stenosis ≥40% on CCTA

Adult patient,- with no diagnosed coronary status or history of stenting or bypass surgery- whose CCTA evaluation by the local radiologist results in at least an intermediate stenosis ≥40% on at least one vessel with indication for FFR measurement.- Who has not expressed opposition to the use of their data.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient,- with no diagnosed coronary status or history of stenting or bypass surgery- whose CCTA evaluation by the local radiologist results in at least an intermediate stenosis ≥40% on at least one vessel with indication for FFR measurement.- Who has not expressed opposition to the use of their data. From one of the participating Investigator centers which are hospitals and clinics in France.

You may qualify if:

• Adult patient,
• with no diagnosed coronary status or history of stenting or bypass surgery
• whose CCTA evaluation by the local radiologist results in at least an intermediate stenosis ≥40% on at least one vessel with indication for FFR measurement.
• Who has not expressed opposition to the use of their data.

You may not qualify if:

• protected populations: patient under guardianship, curatorship or legal protection.

Sponsors & Collaborators

• Institut Mutualiste Montsouris: lead

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Jean-François PAUL, MD

  Institut Mutualiste Montsouris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-François PAUL, MD

CONTACT

0156616171; Jean-Francois.Paul@imm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 12, 2023
• Study Start: April 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 12, 2023

Record last verified: 2023-03