Carotid Risk Prediction (CRISP) Consortium

• Conditions: Carotid Atherosclerosis
• Interventions: Diagnostic Test: vascuCAP

• Registration Number: NCT04448353
• Lead Sponsor: Elucid Bioimaging Inc.

Brief Summary

Develop adverse event prediction and plaque phenotype classification models for patients with known or suspected carotid artery disease.

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 Timeline

• Study Start: 2019-03-01
• Status Verified: 2020-06
• Study First Submitted: 2020-06-23
• Study First Submitted QC: 2020-06-23
• Study First Posted: 2020-06-25
• Last Update Submitted: 2021-02-03
• Last Update Posted: 2021-02-04
• Primary Completion: 2021-12-15
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Development / training	vascuCAP	Selected by stratified partitioning
Sequestered / test	vascuCAP	Selected by stratified partitioning

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

University of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States

Baltimore VA Medical Center; 🇺🇸 Baltimore, Maryland, United States

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States

University Hospital Harrington (Affiliated with Case Western Reserve University); 🇺🇸 Cleveland, Ohio, United States

Weill Cornell Medicine (Affiliated with New York Presbyterian Hospital); 🇺🇸 New York, New York, United States