Carotid Risk Prediction (CRISP) Consortium
CRISP
1 other identifier
observational
800
1 country
5
Brief Summary
Develop adverse event prediction and plaque phenotype classification models for patients with known or suspected carotid artery disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
June 23, 2020
CompletedFirst Posted
Study publicly available on registry
June 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedFebruary 4, 2021
June 1, 2020
2.8 years
June 23, 2020
February 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse outcome model performance
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.
2 years
Study Arms (2)
Development / training
Selected by stratified partitioning
Sequestered / test
Selected by stratified partitioning
Interventions
adverse event and phenotype classification model
Eligibility Criteria
All-comers, design, adjusted for demographic factors
You may qualify if:
- 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.
You may not qualify if:
- Subjects without visible plaque within the carotid artery
- Subject with insufficient CTA image quality (defined strictly as documented in the vascuCAP Reading Manual)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Elucid Bioimaging Inc.lead
- University of Maryland, College Parkcollaborator
Study Sites (5)
Baltimore VA Medical Center
Baltimore, Maryland, 21201, United States
University of Maryland, Baltimore
Baltimore, Maryland, 21201, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814, United States
Weill Cornell Medicine (Affiliated with New York Presbyterian Hospital)
New York, New York, 10065, United States
University Hospital Harrington (Affiliated with Case Western Reserve University)
Cleveland, Ohio, 44106, United States
Related Publications (1)
Lal BK, Khan AA, Kashyap VS, Chrencik MT, Gupta A, King AH, Patel JB, Martinez-Delcid J, Uceda D, Desikan S, Sikdar S, Sorkin JD, Buckler A. Computed tomography angiographic biomarkers help identify vulnerable carotid artery plaque. J Vasc Surg. 2022 Apr;75(4):1311-1322.e3. doi: 10.1016/j.jvs.2021.10.056. Epub 2021 Nov 15.
PMID: 34793923DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brajesh K. Lal, MD
University of Maryland, College Park
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2020
First Posted
June 25, 2020
Study Start
March 1, 2019
Primary Completion
December 15, 2021
Study Completion
April 30, 2022
Last Updated
February 4, 2021
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share