- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06186336
Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque (FOCUS DL)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Melissa Challman
- Phone Number: 8582213007
- Email: melissa.challman@gehealthcare.com
Study Locations
-
-
Lombardy
-
Pavia, Lombardy, Italy, 27100
- Ospedale Di Voghera, Azienda Socio-Sanitaria Territoriale di Pavia
-
Contact:
- Pietro Broglia, MD
- Phone Number: +39 0383 695682
- Email: pietro_broglia@asst-pavia.it
-
Principal Investigator:
- Pietro Broglia, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study 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.
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
DL-Based Vulnerable Plaque Detection and Assessment Tool
Enrolled subjects will receive a clinically indicated CCTA and ICA with OCT within 10 days. At least two qualified CCTA radiologists will independently review and annotate the coronary plaques in the CCTA using their local post-processing tools. At least two trained OCT readers will review and annotate the coronary plaques in the ICA/OCT using their local post-processing tools. The original de-identified CCTA data will be inputted into the Vulnerable Plaque Detection and Assessment Tool. The tool will perform the automatic identification of the plaque location and characteristics. These results will be compared to assess the algorithm's performance. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Data Collection
Time Frame: Through study completion, an average of 1 year
|
Number of subjects with raw CCTA and ICA with OCT data
|
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of Tool
Time Frame: 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
|
Through study completion, an average of 1 year
|
Safety Events
Time Frame: Through study completion, an average of 1 year
|
Number of AEs, SAEs, and product issues
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Paul Deak, GE Healthcare
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12019187648
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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