Carotid Risk Prediction (CRISP) Consortium
Study Details
Study Description
Brief Summary
Develop adverse event prediction and plaque phenotype classification models for patients with known or suspected carotid artery disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Develop adverse event prediction and plaque phenotype classification models using plaque morphology and composition assessment of CTA which has been validated by histology, applied to representative cohort of patients. Generalizability of models is enhanced by using validated rather than only raw image inputs. Demographic, clinical, and outcome data is collected for enrolled patients as well as information on events and interventions.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Development / training Selected by stratified partitioning |
Diagnostic Test: vascuCAP
adverse event and phenotype classification model
|
| Sequestered / test Selected by stratified partitioning |
Diagnostic Test: vascuCAP
adverse event and phenotype classification model
|
Outcome Measures
Primary Outcome Measures
- Adverse outcome model performance [2 years]
Develop adverse event model for major adverse neurological events (MANE) prediction on large retrospective cohort (and enable a prospective collection subsequent to this study). Consistent with this primary endpoint is the evaluation of all imaging-derived data that has a bearing on the diagnosis and prognosis of the subject.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects must have two (or more) neck CTAs at least 6 months apart of sufficient quality as documented in the vascuCAP Reading Manual.
-
Atherosclerotic plaque must be visualized within the carotid artery.
Exclusion Criteria:
-
Subjects without visible plaque within the carotid artery
-
Subject with insufficient CTA image quality (defined strictly as documented in the vascuCAP Reading Manual)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Baltimore VA Medical Center | Baltimore | Maryland | United States | 21201 |
| 2 | University of Maryland, Baltimore | Baltimore | Maryland | United States | 21201 |
| 3 | Walter Reed National Military Medical Center | Bethesda | Maryland | United States | 20814 |
| 4 | Weill Cornell Medicine (Affiliated with New York Presbyterian Hospital) | New York | New York | United States | 10065 |
| 5 | University Hospital Harrington (Affiliated with Case Western Reserve University) | Cleveland | Ohio | United States | 44106 |
Sponsors and Collaborators
- Elucid Bioimaging Inc.
- University of Maryland, College Park
Investigators
- Principal Investigator: Brajesh K. Lal, MD, University of Maryland, College Park
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRISP