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

NCT06186336 | Not Yet Recruiting

• 1 other identifier: 12019187648
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Coronary CT Angiography; Invasive Coronary Angiography; Optical Coherence Tomography; Vulnerable Coronary Plaque

Outcome Measures

Primary Outcomes (1)

• Data Collection

  Number of subjects with raw CCTA and ICA with OCT data

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Accuracy of Tool

  Through study completion, an average of 1 year

• Safety Events

  Through study completion, an average of 1 year

Study Arms (1)

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.

Other: Deep Learning-based Vulnerable Plaque Detection and Assessment Tool

Interventions

Deep Learning-based Vulnerable Plaque Detection and Assessment Tool 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.

DL-Based Vulnerable Plaque Detection and Assessment Tool

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with chronic coronary syndrome or stable angina, as well as patients with signs of acute coronary syndrome who have been ordered a clinically indicated CCTA and will likely be referred to undergo an ICA combined with OCT will be enrolled in this study. Subjects with recent onset or growing angina may be included in the study. Subjects will be representative of the general population expected to undergo cardiac non-invasive and invasive imaging and treatment procedures as standard of care clinical practice. The CCTA and ICA with OCT must be carried out within 10 days one from each other. Clinical decision for a PCI after the diagnostic procedures will not limit the enrollment. To preserve the aspect of the plaque, CCTA must be performed first.

You may qualify if:

• Patients referred for a clinically indicated CCTA and ICA with OCT imaging examinations;
• Diagnosis of chronic coronary syndrome, known CAD, or stable angina; AND,
• Patients with ACS that may undergo a CCTA and not refer directly to the Cath lab for revascularization procedures.

You may not qualify if:

• Contradictions to contrast;
• Contraindications for beta blocker;
• BMI \>30;
• High heart rate ≥75 BPM;
• Atrial Fibrillation;
• Arrythmia or irregular heartbeats;
• Any prior coronary revascularization;
• Presence of pacemaker or implantable cardioverter defibrillator; OR,
• Patients with TAVI/TAVR.

Sponsors & Collaborators

• GE Healthcare: lead
• Azienda Socio-Sanitaria Territoriale di Pavia: collaborator

Study Sites (1)

Ospedale Di Voghera, Azienda Socio-Sanitaria Territoriale di Pavia

Pavia, Lombardy, 27100, Italy

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Deak

  GE Healthcare

  STUDY DIRECTOR

Central Study Contacts

Melissa Challman

CONTACT

8582213007; melissa.challman@gehealthcare.com

Study Design

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

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 2, 2024
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 7, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)