Ultrasound-based Morphometry for the Development of Diagnostic and Prognostic Markers in Current and Chronic Diseases

NCT ID: NCT06829121

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2024-12-01

Brief Summary

Frailty or debility is a geriatric syndrome that primarily affects older patients, but also patients with severe illnesses. It is particularly common among oncology patients, but also among patients with gastrointestinal diseases such as liver cirrhosis or pancreatitis. Sarcopenia, a component of frailty, is defined as a loss of muscle quantity, quality and function. Currently, complex methods such as CT or bioimpedance measurement are available. However, simpler techniques such as ultrasound-based measurement could be alternatives, but require further validation.

The aim of this project is to be able to estimate the prognosis of patients at an early stage by measuring sarcopenia using sonography.

Detailed Description

Frailty is a well-known syndrome that has a negative impact on many diseases and the course of disease. Patients affected by frailty are particularly vulnerable due to their inadequate ability to deal with extrinsic and intrinsic stress factors. The prevalence of frailty increases with age, affecting 15% of people over the age of 65 and 25% of people over the age of 80.

Frailty is the end result of an interplay between malnutrition, cognitive impairment and muscle wasting. Each of these factors can be further examined and measured, but they also influence each other. In particular, reduced muscle mass and muscle function have been associated with poor quality of life and a worse course of disease. Sarcopenia is therefore becoming an increasingly important factor in various disease patterns and should be monitored further. Muscle wasting and sarcopenia have multifactorial causes. Physical inactivity, chronic inflammation associated with chronic diseases, and malnutrition are particularly noteworthy in this context. Cross-sectional measurement of several muscles at the level of the lumbar vertebrae (L3), normalized to body size, and dual-energy X-ray absorptiometry are currently the most commonly used techniques for measuring sarcopenia. However, the measurements require complex equipment and procedures. In addition, radiological imaging is costly and causes radiation exposure. Therefore, attempts have been made in the past to simplify the measurements. Sonographic measurement is a practical alternative. Many different muscle groups are accessible to ultrasound. In particular, the thigh muscles and the psoas major muscle can be easily visualized sonographically. The sonographic assessment of the psoas muscle area index (PMAI) and the thigh muscle thickness index (TMTI) are approaches for bedside morphometry that the investigators use primarily.

Sarcopenia needs to be further investigated and included in the evaluation of therapeutic concepts. Recently, Zhang et al. showed that radiologically measured reduced psoas muscle mass was associated with poorer overall survival in HCC patients. Furthermore, it has been suggested several times that sarcopenia should be integrated into the MELD classification for liver transplantation. The investigators were also recently able to show in a cohort of COVID-19 patients that reduced muscle mass was associated with a poorer disease course during the pandemic.

The investigators expect sonographic measurements of the musculature to provide a better assessment of prognosis, quality of life and functional results under therapy.

Conditions

Ultrasound; Sarcopenia; Muscle Loss

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ultrasound patients

Patients who receive a standard ultrasound also get a measurement of the musculature.

Ultrasound

Intervention Type: DIAGNOSTIC_TEST

The thickness of the psoas muscle and the musculus quadriceps femoris will be measured by ultrasound

Interventions

Ultrasound

The thickness of the psoas muscle and the musculus quadriceps femoris will be measured by ultrasound

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• All patients who receive a planned ultrasound examination as part of their outpatient or inpatient evaluation during the planned period.
• All patients over 18 years of age.

Exclusion Criteria

• Patients under 18 years of age.
• Patients unable to give consent.
• Patients with neuromuscular disorders.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitatsmedizin Mainz - 1. Medizinische Klinik

OTHER

Sponsor Role: lead

Responsible Party

Wolfgang Maximilian Kremer

Senior physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wolfgang Maximilian Kremer WMK Kremer, MD

Role: PRINCIPAL_INVESTIGATOR

Universitatsmedizin Mainz

Locations

Universitatsmedizin Mainz

Mainz, Rhineland-Palatinate, Germany

Countries

Germany

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Other Identifiers

2020-15174

Identifier Type: -

Identifier Source: org_study_id