CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,296 enrolled
Drug / intervention
Radiological tool for the diagnosis of myosteatosis +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06593015
NCT06593015N/ACompleted

Study Protocol to Redefine Muscle Attenuation Cut-offs for Better Prediction of Mortality in Patients With Cirrhosis: a Comprehensive Post-hoc Validation Study

University of Roma La Sapienza·observational·Posted Sep 19, 2024·Updated Sep 19, 2024

In Brief

An observational study evaluating Radiological tool for the diagnosis of myosteatosis for Cirrhosis and 5 related conditions. Completed, enrolled 1,296 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedSep 19, 2024
Enrollment StartJan 1, 2019
Primary CompletionDec 1, 2021
Study CompletionFeb 2, 2024
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 1.8 years ago

Interventions

Radiological tool for the diagnosis of myosteatosisother

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

Radiological tool for the diagnosis of myosteatosisother

Calculation of muscle attenuation at L3/L4 CT scan for each patients and evaluation of the relationship between muscle attenuation values and survival