NCT05612555

Brief Summary

The frailty syndrome is important to consider in perioperative cardiac assistance. One of its components is the patient's sarcopenia. This can be assessed by measuring the size of the psoas muscle. For this purpose, one of the most studied measures seems to be the measurement of the Psoas Index. This is a contouring of the psoas muscle, performed on an axial section of a CT scan, at the level of the L4 vertebra, which is then matched to the body surface. However, there is no standardization of measurements and volume acquisitions, and different image processing is also described. A radiological evaluation of the psoas could overcome this difficulty and provide a rapid and available screening tool for sarcopenia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2020

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 10, 2022

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

November 3, 2022

Last Update Submit

December 13, 2023

Conditions

Keywords

Ventricular Assist DeviceVADSarcopeniaPsoas IndexCardiac assistanceCardiac assistance surgery

Outcome Measures

Primary Outcomes (1)

  • Impact of sarcopenia, measured by the Psoas Index, on 28-day survival in patients undergoing cardiac assistance surgery

    Survival at 28 days after surgery

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Major subject ((≥18 years old) having surgery for placement of a ventricular assist device between 01/02/2014 and 30/06/2018 in Strasbourg University Hospital

You may qualify if:

  • Major subject ((≥18 years old)
  • Subject who underwent surgery for placement of a ventricular assist device between 01/02/2014 and 30/06/2018
  • Subject who has not expressed opposition to the reuse of his or her data for research purposes

You may not qualify if:

  • Subject having expressed opposition to participate in the study
  • Absence of CT scan available at the time of implantation or CT scans older than one year prior to surgery and those older than 72 hours postoperatively
  • No anthropometric data available
  • Subject under legal protection
  • Subject under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Réanimation Chirurgicale - CHU de Strasbourg - France

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2022

First Posted

November 10, 2022

Study Start

September 9, 2019

Primary Completion

July 9, 2020

Study Completion

September 9, 2020

Last Updated

December 14, 2023

Record last verified: 2023-12

Locations