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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05264051
Recruitment Status : Recruiting
First Posted : March 3, 2022
Last Update Posted : March 3, 2022
Sponsor:
Information provided by (Responsible Party):
Maria Newsome, University of Chicago

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
Liver Diseases

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

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Study Type : Observational
Estimated 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
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : March 1, 2027
Estimated Study Completion Date : March 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases




Primary Outcome Measures :
  1. Waitlist Mortality [ Time Frame: Measured up to 10 years out from enrollment ]
    Death prior to liver transplant or delisting from enrollment in the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pts. hospitalized with acute hepatic decompensation Pts. with hepatobiliary neoplasia Pts. undergoing TIPS placement Pts. with chroinic liver disease
Criteria

Inclusion Criteria:

  • Patients who are already scheduled for an MRI for routine clinical purposes will be evaluated

Exclusion Criteria:

  • <18 yrs. of age

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): NCT05264051


Contacts
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Contact: Omar Jamil, MD 847-373-2360 Omar.Jamil@uchospitals.edu
Contact: Maria Newsome 773-702-2788 mnewsome1@bsd.uchicago.edu

Locations
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United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Maria Newsome    773-702-2788    mnewsome1@bsd.uchicago.edu   
Contact: Omar Jamal, MD    773-702-0309    Omar.Jamil@uchospitals.edu   
Principal Investigator: Michael Charlton, MD         
Sponsors and Collaborators
University of Chicago
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Responsible Party: Maria Newsome, Clinical Research Coordinator, University of Chicago
ClinicalTrials.gov Identifier: NCT05264051    
Other Study ID Numbers: IRB21-0900
First Posted: March 3, 2022    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases