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Carotid Risk Prediction (CRISP) Consortium (CRISP)

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ClinicalTrials.gov Identifier: NCT04448353
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : February 4, 2021
Sponsor:
Collaborator:
University of Maryland, College Park
Information provided by (Responsible Party):
Elucid Bioimaging Inc.

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
Carotid Atherosclerosis 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.

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Carotid Risk Prediction (CRISP) Consortium
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : April 30, 2022

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




Primary Outcome Measures :
  1. Adverse outcome model performance [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All-comers, design, adjusted for demographic factors
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04448353


Contacts
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Contact: Andrew J Buckler, MS 9784731986 andrew.buckler@elucidbio.com

Locations
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United States, Maryland
Baltimore VA Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Brajesh K Lal, MD    410-328-5840    blal@som.umaryland.edu   
University of Maryland, Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Brajesh K Lal, MD    410-328-5840    blal@som.umaryland.edu   
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20814
Contact: Kevin DeMarco, MD    301-295-4428    james.k.demarco.civ@mail.mil   
United States, New York
Weill Cornell Medicine (Affiliated with New York Presbyterian Hospital) Recruiting
New York, New York, United States, 10065
Contact: Ajay Gupta, MD    212-746-6000    ajg9004@med.cornell.edu   
United States, Ohio
University Hospital Harrington (Affiliated with Case Western Reserve University) Recruiting
Cleveland, Ohio, United States, 44106
Contact: Vikram Kashyap, MD    216-250-9840    vikram.kashyap@uhhospitals.org   
Sponsors and Collaborators
Elucid Bioimaging Inc.
University of Maryland, College Park
Investigators
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Principal Investigator: Brajesh K. Lal, MD University of Maryland, College Park
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Responsible Party: Elucid Bioimaging Inc.
ClinicalTrials.gov Identifier: NCT04448353    
Other Study ID Numbers: CRISP
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Carotid Artery Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases