Carotid Risk Prediction (CRISP) Consortium

Carotid Atherosclerosis Clinical Trial

— CRISP  

Official title:

Carotid Risk Prediction (CRISP) Consortium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04448353
• Other study ID #: CRISP
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: June 2020
• Source: Elucid Bioimaging Inc.
• Contact: Andrew J Buckler, MS
• Phone: 9784731986
• Email: andrew.buckler[@]elucidbio.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: April 30, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis

Intervention

Diagnostic Test:
• vascuCAP
adverse event and phenotype classification model

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center	Baltimore	Maryland
United States	University of Maryland, Baltimore	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

Sponsors (2)

Lead Sponsor	Collaborator
Elucid Bioimaging Inc.	University of Maryland, College Park

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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