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MAsS Scan as a Predictor of Morbidity and Mortality in Patients With Liver Disease

Sponsor
University of Chicago (Other)
Overall Status
Recruiting
CT.gov ID
NCT05264051
Collaborator
(none)
1,200
Enrollment
1
Location
60
Anticipated Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to study the muscle assessment score (MAsS, utilizing MRI, as an objective measure of frailty and muscle composition to serve as a predictor of morbidity and mortality in patients with liver disease.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Prospective study of patients seen at the Univ. of Chicago Medical Center hospital and ambulatory clinics. The assessment of the MAsS score will require an additional 8-10 minutes in the MRI for each patient already undergoing MRI exam.

    Four groups of pts. who are already scheduled for MRI for routine clinical purposes will be evaluated.

    1. Pts. hospitalized with acute hepatic decompensation for whom MRI is otherwise indicated for clinical evaluation.

    2. Pts. with hepatobiliary neoplasia

    3. Pts.undergoing transjugular portosystemic shunt (TIPS) placement

    4. Pts. with chronic liver disease undergoing magnetic resonance elastography for routine monitoring

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    MAsS Scan as a Predictor of Morbidity and Mortality in Patients With Liver Disease
    Anticipated Study Start Date :
    Mar 1, 2022
    Anticipated Primary Completion Date :
    Mar 1, 2027
    Anticipated Study Completion Date :
    Mar 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Waitlist Mortality [Measured up to 10 years out from enrollment]

      Death prior to liver transplant or delisting from enrollment in the study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who are already scheduled for an MRI for routine clinical purposes will be evaluated
    Exclusion Criteria:
    • <18 yrs. of age

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Chicago Chicago Illinois United States 60637

    Sponsors and Collaborators

    • University of Chicago

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maria Newsome, Clinical Research Coordinator, University of Chicago
    ClinicalTrials.gov Identifier:
    NCT05264051
    Other Study ID Numbers:
    • IRB21-0900
    First Posted:
    Mar 3, 2022
    Last Update Posted:
    Mar 3, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Diseases

    Study Results

    No Results Posted as of Mar 3, 2022