Carotid Risk Prediction (CRISP) Consortium (CRISP)

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

Study Overview

• Status: Unknown
• Conditions: Carotid Atherosclerosis
• Intervention / Treatment: Diagnostic test: vascuCAP

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 Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

• Study Contact: Name: Andrew J Buckler, MS; Phone Number: 9784731986; Email: andrew.buckler@elucidbio.com

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • Baltimore VA Medical Center
      • Contact: Brajesh K Lal, MD; Phone Number: 410-328-5840; Email: blal@som.umaryland.edu
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland, Baltimore
      • Contact: Brajesh K Lal, MD; Phone Number: 410-328-5840; Email: blal@som.umaryland.edu
    • Bethesda, Maryland, United States, 20814
      • Recruiting
      • Walter Reed National Military Medical Center
      • Contact: Kevin DeMarco, MD; Phone Number: 301-295-4428; Email: james.k.demarco.civ@mail.mil
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine (Affiliated with New York Presbyterian Hospital)
      • Contact: Ajay Gupta, MD; Phone Number: 212-746-6000; Email: ajg9004@med.cornell.edu
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospital Harrington (Affiliated with Case Western Reserve University)
      • Contact: Vikram Kashyap, MD; Phone Number: 216-250-9840; Email: vikram.kashyap@uhhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All-comers, design, adjusted for demographic factors

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Elucid Bioimaging Inc.
• Collaborators: University of Maryland, College Park
• Investigators: Principal Investigator: Brajesh K. Lal, MD, University of Maryland, College Park

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ANTICIPATED): December 15, 2021
• Study Completion (ANTICIPATED): April 30, 2022

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (ACTUAL): June 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Carotid Artery Diseases; Atherosclerosis
• Other Study ID Numbers: CRISP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes