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

Not yet recruitingOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

January 31, 2025

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
Chronic Coronary SyndromeCoronary Artery DiseaseStable AnginaAcute Coronary Syndrome
Interventions
OTHER

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."

Trial Locations (1)

27100

Ospedale Di Voghera, Azienda Socio-Sanitaria Territoriale di Pavia, Pavia

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Azienda Socio-Sanitaria Territoriale di Pavia

UNKNOWN

lead

GE Healthcare

INDUSTRY