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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06186336
Other study ID # 12019187648
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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