- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06864247
Evaluating the Impact of Psoas Muscle Size, Composition, and Clinical Frailty on Long-term Outcomes Following Elective Endovascular Aneurysm Repair
Evaluating the Impact of Psoas Muscle Size, Composition, and Clinical Frailty on Long-term Outcomes Following Elective Endovascular Aneurysm Repair: a Multicenter Retrospective Study
Sarcopenia, which is characterized by the progressive loss of skeletal muscle mass and strength, has emerged as a significant prognostic biomarker in the field of vascular surgery, particularly regarding endovascular aneurysm repair (EVAR). This article delves into the implications of sarcopenia on the outcomes of EVAR, emphasizing its predictive value for long-term survival and potential as a tool for patient risk stratification.
Recent research suggests that sarcopenia could be used as a biomarker for prognosis. A systematic review and meta-analysis have underscored sarcopenia's negative prognostic value for survival during long-term follow-up post-EVAR. The presence of sarcopenia, as determined by decreased core muscle area in axial abdominal computed tomography (CT) scans, has been widely discussed as a predictor of outcomes in patients undergoing EVAR.1
Moreover, studies have consistently reported an association between sarcopenia and increased mortality and adverse outcomes following EVAR.2 For instance, a retrospective review investigating sarcopenia as a method to predict 1-year survival in patients undergoing EVAR found a significant increase in overall mortality among patients with the lowest quartile of normalized total psoas cross-sectional area (nTPA).2 Therefore, researchers suggested that physicians can use sarcopenia for risk stratification and patient selection before an EVAR. The evaluation of sarcopenia from preoperative CT scans can assist clinicians in identifying EVAR candidates who may be less likely to benefit from the procedure.2 This objective radiographic finding offers a standardized method for patient selection, which could be particularly useful in telemedicine and remote patient evaluation.
The integration of sarcopenia assessment into the preoperative evaluation of patients considered for EVAR can revolutionize the approach to managing abdominal aortic aneurysms (AAA). By providing a reliable biomarker for risk stratification, sarcopenia can enable a more personalized treatment plan, potentially improving patient outcomes and optimizing healthcare resources. Nonetheless, the majority of the studies were conducted among Western populations. The implications are questionable for Taiwan patients. This study aims to fill the gap and to analyze the sarcopenia and its impact on patient outcomes following EVAR in Taiwan
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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New taipei city, Taiwan, 100
- National Taiwan University Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- The AAA patients undergoing EVAR procedures
Exclusion Criteria:
- The AAA patients undergoing open surgery procedures
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
The AAA patients undergoing EVAR procedures
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Death
Time Frame: From enrollment to the end at 8 years
|
The social security death was queried to confirm all deaths and survey patients lost to follow-ups
|
From enrollment to the end at 8 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical outcomes
Time Frame: From enrollment to the end at 8 years
|
Clinical adverse events, number of participants with cardiac events, number of participants with cerebrovascular events, number of participants with amputation events, number of participants with accesssite events, number of participants with reintervention events.
|
From enrollment to the end at 8 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202407056RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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