- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05612555
Low Psoas Index and Cardiac Assistance: No Excess Mortality at D28 Post Implantation (VAD)
December 13, 2023 updated by: University Hospital, Strasbourg, France
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
65
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Strasbourg, France, 67091
- Service de Réanimation Chirurgicale - CHU de Strasbourg - France
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-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
Description
Inclusion criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Impact of sarcopenia, measured by the Psoas Index, on 28-day survival in patients undergoing cardiac assistance surgery
Time Frame: Survival at 28 days after surgery
|
Survival at 28 days after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 9, 2019
Primary Completion (Actual)
July 9, 2020
Study Completion (Actual)
September 9, 2020
Study Registration Dates
First Submitted
November 3, 2022
First Submitted That Met QC Criteria
November 3, 2022
First Posted (Actual)
November 10, 2022
Study Record Updates
Last Update Posted (Estimated)
December 14, 2023
Last Update Submitted That Met QC Criteria
December 13, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 7531
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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