Low Psoas Index and Cardiac Assistance: No Excess Mortality at D28 Post Implantation

Ventricular Assist Device Clinical Trial

— VAD  

Official title:

Low Psoas Index and Cardiac Assistance: No Excess Mortality at D28 Post Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05612555
• Other study ID #: 7531
• Status: Completed
• Start date: September 9, 2019
• Est. completion date: September 9, 2020

Study information

• Verified date: December 2023
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 9, 2020
• Est. primary completion date: July 9, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ventricular Assist Device

Locations

Country	Name	City	State
France	Service de Réanimation Chirurgicale - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of sarcopenia, measured by the Psoas Index, on 28-day survival in patients undergoing cardiac assistance surgery		Survival at 28 days after surgery