Coronary Artery Disease Clinical Trial
— FOCUS DLOfficial title:
Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque
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.
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale Di Voghera, Azienda Socio-Sanitaria Territoriale di Pavia | Pavia | Lombardy |
Lead Sponsor | Collaborator |
---|---|
GE Healthcare | Azienda Socio-Sanitaria Territoriale di Pavia |
Italy,
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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