NCT06864247

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
525

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2025

Completed
Last Updated

March 12, 2025

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

March 3, 2025

Last Update Submit

March 7, 2025

Conditions

Keywords

Endovascular Aneurysm Repair (EVAR)SarcopeniaMyosteatosisFrailty

Outcome Measures

Primary Outcomes (1)

  • Death

    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 Outcomes (1)

  • Clinical outcomes

    From enrollment to the end at 8 years

Study Arms (1)

The AAA patients undergoing EVAR procedures

Other: No Intervention: Observational Cohort

Interventions

No intervention

The AAA patients undergoing EVAR procedures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The AAA patients undergoing EVAR procedures

You may qualify if:

  • The AAA patients undergoing EVAR procedures

You may not qualify if:

  • The AAA patients undergoing open surgery procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

New Taipei City, 100, Taiwan

Location

MeSH Terms

Conditions

SarcopeniaFrailty

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

March 3, 2025

First Posted

March 7, 2025

Study Start

September 1, 2024

Primary Completion

January 3, 2025

Study Completion

March 3, 2025

Last Updated

March 12, 2025

Record last verified: 2024-08

Locations