Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque (FOCUS DL)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Stable Angina; Chronic Coronary Syndrome
• Intervention / Treatment: Other: Deep Learning-based Vulnerable Plaque Detection and Assessment Tool

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Melissa Challman; Phone Number: 8582213007; Email: melissa.challman@gehealthcare.com

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Ospedale Di Voghera, Azienda Socio-Sanitaria Territoriale di Pavia
      • Contact: Pietro Broglia, MD; Phone Number: +39 0383 695682; Email: pietro_broglia@asst-pavia.it
      • Contact: Pietro Broglia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data Collection	Number of subjects with raw CCTA and ICA with OCT data	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through study completion, an average of 1 year
Safety Events	Number of AEs, SAEs, and product issues	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: Azienda Socio-Sanitaria Territoriale di Pavia
• Investigators: Study Director: Paul Deak, GE Healthcare

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography; Invasive Coronary Angiography; Vulnerable Coronary Plaque; Coronary CT Angiography
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Chest Pain; Angina Pectoris; Syndrome; Coronary Artery Disease; Acute Coronary Syndrome; Angina, Stable
• Other Study ID Numbers: 12019187648

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No