Acute Coronary Syndrome, Chronic Coronary Syndrome, Coronary Artery Disease, Stable Angina
Conditions
Keywords
Coronary CT Angiography, Invasive Coronary Angiography, Optical Coherence Tomography, Vulnerable Coronary Plaque
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 identification of the plaque and associated vulnerability grade.
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.
Interventions
OTHERDeep 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.
Sponsors
Azienda Socio-Sanitaria Territoriale di Pavia
GE Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Data Collection | Through study completion, an average of 1 year | Number of subjects with raw CCTA and ICA with OCT data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Tool | Through study completion, an average of 1 year | 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 |
| Safety Events | Through study completion, an average of 1 year | Number of AEs, SAEs, and product issues |
Countries
Italy
Contacts
Primary ContactMelissa Challman
Outcome results
None listed