Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque

NCT ID: NCT06186336

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2025-06-30

Brief Summary

The primary objective of this study is to assess the accuracy in terms of sensitivity, specificity, negative and positive predicted values of the DL-based algorithm with respect to correct identification of the plaque and associated vulnerability grade.

Detailed Description

Data collected in this study will be used for technology development, scientific evaluation, education, and regulatory submissions for future products. This is a pre-market, open label, prospective, non-randomized clinical research study conducted at one site in Italy. The product being researched is the Deep Learning-based (DL) algorithm for non-invasive detection of vulnerable coronary plaque.

Conditions

Chronic Coronary Syndrome; Coronary Artery Disease; Stable Angina; Acute Coronary Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

DL-Based Vulnerable Plaque Detection and Assessment Tool

Enrolled subjects will receive a clinically indicated CCTA and ICA with OCT within 10 days. At least two qualified CCTA radiologists will independently review and annotate the coronary plaques in the CCTA using their local post-processing tools. At least two trained OCT readers will review and annotate the coronary plaques in the ICA/OCT using their local post-processing tools.

The original de-identified CCTA data will be inputted into the Vulnerable Plaque Detection and Assessment Tool. The tool will perform the automatic identification of the plaque location and characteristics. These results will be compared to assess the algorithm's performance.

Deep Learning-based Vulnerable Plaque Detection and Assessment Tool

Intervention Type: OTHER

Scanning requirements for the clinically indicated CCTA and ICA with OCT will be performed according to current site(s) guidelines and procedures. Administration of medications (such as contrast agents and potentially beta-blockers and other medications) will be given according to standard hospital care.

This is a prospective research study evaluating an investigational product. The tool's use is intended for research purposes and is not intended as a substitute for required medical care. The CCTA and ICA with OCT will be processed in real-time using the site's locally available post-processing tools in order to guide the subject's medical care. Once the ICA with OCT is complete, the de-identified CCTA data will be inputted in the investigational tool.

The clinically indicated CCTA and the ICA with OCT will both take approximately 1 hour and will take place within 10 days. No additional imaging is needed as part of the study.

Interventions

Deep Learning-based Vulnerable Plaque Detection and Assessment Tool

Scanning requirements for the clinically indicated CCTA and ICA with OCT will be performed according to current site(s) guidelines and procedures. Administration of medications (such as contrast agents and potentially beta-blockers and other medications) will be given according to standard hospital care.

This is a prospective research study evaluating an investigational product. The tool's use is intended for research purposes and is not intended as a substitute for required medical care. The CCTA and ICA with OCT will be processed in real-time using the site's locally available post-processing tools in order to guide the subject's medical care. Once the ICA with OCT is complete, the de-identified CCTA data will be inputted in the investigational tool.

The clinically indicated CCTA and the ICA with OCT will both take approximately 1 hour and will take place within 10 days. No additional imaging is needed as part of the study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients referred for a clinically indicated CCTA and ICA with OCT imaging examinations;

2. Diagnosis of chronic coronary syndrome, known CAD, or stable angina; AND,

3. Patients with ACS that may undergo a CCTA and not refer directly to the Cath lab for revascularization procedures.

Exclusion Criteria

1. Contradictions to contrast;

2. Contraindications for beta blocker;

3. BMI >30;

4. High heart rate ≥75 BPM;

5. Atrial Fibrillation;

6. Arrythmia or irregular heartbeats;

7. Any prior coronary revascularization;

8. Presence of pacemaker or implantable cardioverter defibrillator; OR,

9. Patients with TAVI/TAVR.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Socio-Sanitaria Territoriale di Pavia

UNKNOWN

Sponsor Role: collaborator

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Deak

Role: STUDY_DIRECTOR

GE Healthcare

Locations

Ospedale Di Voghera, Azienda Socio-Sanitaria Territoriale di Pavia

Pavia, Lombardy, Italy

Countries

Italy

Central Contacts

Melissa Challman

Role: CONTACT

melissa.challman@gehealthcare.com

8582213007

Facility Contacts

Pietro Broglia, MD

Role: primary

pietro_broglia@asst-pavia.it

+39 0383 695682

Pietro Broglia, MD

Role: backup

Other Identifiers

12019187648

Identifier Type: -

Identifier Source: org_study_id