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

N/ANot Yet RecruitingNCT06186336

GE Healthcare200 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Chronic Coronary Syndrome Coronary Artery Disease Stable Angina Acute Coronary Syndrome

Interventions

Deep Learning-based Vulnerable Plaque Detection and Assessment ToolOTHER

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Ospedale Di Voghera, Azienda Socio-Sanitaria Territoriale di Pavia

Pavia, Lombardy, Italy

Outcomes

Primary Outcomes

Data Collection

Number of subjects with raw CCTA and ICA with OCT data

Time frame: Through study completion, an average of 1 year

Secondary Outcomes

Accuracy of Tool

Sensitivity, specificity, negative, and positive predicted values of the DL-based algorithm with respect to correct identification of the plaque and associated vulnerability grade in comparison to qualified readers

Time frame: Through study completion, an average of 1 year

Safety Events

Number of AEs, SAEs, and product issues

Time frame: Through study completion, an average of 1 year

Central Contacts

Melissa Challman

CONTACT

8582213007 melissa.challman@gehealthcare.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.