Protocol for Muscle Attenuation Cut-offs in Cirrhosis

NCT06593015 | Completed

• 1 other identifier: Prot n 94/19
• Study Type: observational
• Target: 1,296
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn if new muscle attenuation cut-offs for the definition of myosteatosis can better predict survival in patients with cirrhosis. The main questions it aims to answer are:

• Can these new muscle attenuation cut-offs more accurately diagnose myosteatosis (fat infiltration in muscle mass ) in cirrhosis?
• Do these cut-offs work effectively across different patient groups, including men and women, those with obesity, and those with fluid retention in the abdomen? Researchers will compare patients with cirrhosis from a retrospective Canadian cohort to those from a prospective Italian cohort to see if the new cut-offs predict survival better than existing ones\*\*. Due to the retrospective nature of the study, no action is required from participants.

Conditions

Cirrhosis; Myosteatosis; Sarcopenia; Sarcopenia in Liver Cirrhosis; Portal Hypertension Related to Cirrhosis; Malnutrition

Keywords

cirrhosis; myosteatosis; cut-offs; diagnosis; sex; muscle attenuation; malnutrition

Outcome Measures

Primary Outcomes (1)

• Definition of new L3/L3-L4 muscle attenuation cut-offs to define myosteatosis in relation to risk of death in patients with cirrhosis

  The primary outcome is the validation of L3 / L3-L4 muscle attenuation values associated with the overall risk of death. Liver transplantation will be considered as a competing event in any analysis of the clinical impact of muscle damage, according to the above definition and classification.

  12 months

Secondary Outcomes (1)

• Association of newly defined myosteatosis with risk of clinical events in patients with cirrhosis

  12 months

Study Arms (2)

Prospective cohort: Department of Translational and Precision Medicine, Sapienza University of Rome

The prospective cohort in this study consists of patients with cirrhosis who were prospectively enrolled from 26 different centres across Italy (EpatoSarco groups) between January 2019 and January 2020. The cohort includes a total of 447 patients aged between 40 and 75 years, who underwent abdominal CT scans for various clinical indications. The results of the original study were already published in May 2024.

Diagnostic Test: Radiological tool for the diagnosis of myosteatosis

Retrospective group: University of Alberta, Edmonton, Alberta, Canada

The retrospective cohort in this study comprises patients with cirrhosis who were evaluated for liver transplantation (LT) at the University of Alberta Hospital in Canada. This cohort includes 1,104 patients who underwent CT imaging as part of their LT evaluation between January 2000 and August 2021. After applying specific exclusion criteria, 863 patients were ultimately included in the analysis. The results of the original study were already published in Apr 2022

Diagnostic Test: Radiological tool for the diagnosis of myosteatosis

Interventions

Radiological tool for the diagnosis of myosteatosis DIAGNOSTIC_TEST

Calculation of muscle attenuation at L3 CT scan for each patients and evaluation of the relationship between muscle attenuation values and survival

Retrospective group: University of Alberta, Edmonton, Alberta, Canada

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In the retrospective cohort, 1104 patients were evaluated for LT between January 2000 and August 2021 in the University of Alberta Hospital (Canada), of whom 241 were excluded for not meeting the inclusion and exclusion criteria, so 863 patients were considered for the analysis. In the prospective cohort, 447 patients were prospectively enrolled from 26 Italian centres, 14 of whom were excluded due to incomplete data, leaving 433 patients for the analysis.

You may qualify if:

• Retrospective cohort:
• Clinical, radiological and/or histological diagnosis of cirrhosis
• Abdominal CT-scan obtained as part of the LT evaluation
• Prospective cohort:
• Clinical, radiological and/or histological diagnosis of cirrhosis
• Age 40-75 years
• Abdominal CT-scan

You may not qualify if:

• Retrospective cohort:
• Multi-organ transplantation
• Re-transplantation
• Prospective cohort:
• Patient on LT waiting lists
• Hepatocellular carcinoma (HCC)
• History of LT
• Concomitant neuromuscular disease
• Current malignancy other than non-melanocytic skin cancer
• History of serious extrahepatic disease
• HIV infection.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Department of Translational and Precision Medicine, Sapienza University of Rome

Rome, Italy, 00185, Italy

Location

Related Publications (3)

• Ebadi M, Tsien C, Bhanji RA, Dunichand-Hoedl AR, Rider E, Motamedrad M, Mazurak VC, Baracos V, Montano-Loza AJ. Skeletal Muscle Pathological Fat Infiltration (Myosteatosis) Is Associated with Higher Mortality in Patients with Cirrhosis. Cells. 2022 Apr 14;11(8):1345. doi: 10.3390/cells11081345.

  PMID: 35456024 BACKGROUND

• Mehta G, Riva A, Ballester MP, Uson E, Pujadas M, Carvalho-Gomes A, Sahuco I, Bono A, D'Amico F, Vigano R, Diago E, Lanseros BT, Inglese E, Vazquez DM, Sharma R, Tsou HLP, Harris N, Broekhoven A, Kikkert M, Morales SPT, Myeni SK, Riveiro-Barciela M, Palom A, Zeni N, Brocca A, Cussigh A, Cmet S, Escudero-Garcia D, Stocco M, Natola LA, Ieluzzi D, Paon V, Sangiovanni A, Farina E, di Benedetto C, Sanchez-Torrijos Y, Lucena-Varela A, Roman E, Sanchez E, Sanchez-Aldehuelo R, Lopez-Cardona J, Canas-Perez I, Eastgate C, Jeyanesan D, Morocho AE, Di Cola S, Lapenna L, Zaccherini G, Bongiovanni D, Zanaga P, Sayaf K, Hossain S, Crespo J, Robles-Diaz M, Madejon A, Degroote H, Fernandez J, Korenjak M, Verhelst X, Garcia-Samaniego J, Andrade RJ, Iruzubieta P, Wright G, Caraceni P, Merli M, Patel VC, Gander A, Albillos A, Soriano G, Donato MF, Sacerdoti D, Toniutto P, Buti M, Duvoux C, Grossi PA, Berg T, Polak WG, Puoti M, Bosch-Comas A, Belli L, Burra P, Russo FP, Coenraad M, Calleja JL, Perricone G, Berenguer M, Claria J, Moreau R, Arroyo V, Angeli P, Sanchez C, Ampuero J, Piano S, Chokshi S, Jalan R; COBALT Consortium. Serological response and breakthrough infection after COVID-19 vaccination in patients with cirrhosis and post-liver transplant. Hepatol Commun. 2023 Oct 18;7(11):e0273. doi: 10.1097/HC9.0000000000000273. eCollection 2023 Nov 1.

  PMID: 37870985 BACKGROUND

• Di Cola S, D'Amico G, Motamedrad M, Montano-Loza A, Merli M. Study protocol to redefine muscle attenuation cut-offs for better prediction of mortality in patients with cirrhosis: a comprehensive post hoc validation study - a study protocol. BMJ Open. 2025 Mar 25;15(3):e094252. doi: 10.1136/bmjopen-2024-094252.

  PMID: 40132832 DERIVED

MeSH Terms

Conditions

Fibrosis; Sarcopenia; Malnutrition; Disease; Coitus

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Sexual Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: February 2, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)