Status:
NOT_YET_RECRUITING
Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque
Lead Sponsor:
GE Healthcare
Collaborating Sponsors:
Azienda Socio-Sanitaria Territoriale di Pavia
Conditions:
Chronic Coronary Syndrome
Coronary Artery Disease
Eligibility:
All Genders
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 identificat...
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, n...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06186336
Start Date
January 1 2025
End Date
June 1 2025
Last Update
January 7 2025
Active Locations (1)
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1
Ospedale Di Voghera, Azienda Socio-Sanitaria Territoriale di Pavia
Pavia, Lombardy, Italy, 27100