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

Coronary Artery Disease Clinical Trial

— FOCUS DL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06186336
• Other study ID #: 12019187648
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: December 2024

Study information

• Verified date: June 2024
• Source: GE Healthcare
• Contact: Melissa Challman
• Phone: 8582213007
• Email: melissa.challman[@]gehealthcare.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Stable
• Chronic Coronary Syndrome
• Coronary Artery Disease
• Stable Angina
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Italy	Ospedale Di Voghera, Azienda Socio-Sanitaria Territoriale di Pavia	Pavia	Lombardy

Sponsors (2)

Lead Sponsor	Collaborator
GE Healthcare	Azienda Socio-Sanitaria Territoriale di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data Collection	Number of subjects with raw CCTA and ICA with OCT data	Through study completion, an average of 1 year
Secondary	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
Secondary	Safety Events	Number of AEs, SAEs, and product issues	Through study completion, an average of 1 year