Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorGE Healthcare
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Contradictions to contrast;
Contraindications for beta blocker;
BMI >30;
High heart rate ≥75 BPM;
Trial population
Subjects with chronic coronary syndrome or stable angina, as well as patients with signs of acute coronary syndrome who have been ordered a clinically indicated CCTA and will likely be referred to undergo an ICA combined with OCT will be enrolled in this study. Subjects with recent onset or growing angina may be included in the study. Subjects will be representative of the general population expected to undergo cardiac non-invasive and invasive imaging and treatment procedures as standard of care clinical practice. The CCTA and ICA with OCT must be carried out within 10 days one from each other. Clinical decision for a PCI after the diagnostic procedures will not limit the enrollment. To preserve the aspect of the plaque, CCTA must be performed first.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Deep Learning-based Vulnerable Plaque Detection and Assessment Tool
Other interventionScanning 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: DL-Based Vulnerable Plaque Detection and Assessment Tool1 intervention
Trial outcomes
Primary outcomes
1
Data Collection
Number of subjects with raw CCTA and ICA with OCT data
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
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
Time frame
Through study completion, an average of 1 year2
Safety Events
Number of AEs, SAEs, and product issues
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
GE Healthcare
Lead sponsor
Azienda Socio-Sanitaria Territoriale di Pavia
Collaborator
Source ClinicalTrials.gov
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