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Completed

NCT Number: NCT06864247

Evaluating the Impact of Psoas Muscle Size, Composition, and Clinical Frailty on Long-term Outcomes Following Elective Endovascular Aneurysm Repair

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

New Taipei City, 100, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The AAA patients undergoing EVAR procedures

Exclusion criteria

  • The AAA patients undergoing open surgery procedures

Treatment and study plan

No Intervention: Observational Cohort

Other

No intervention

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Evaluating the Impact of Psoas Muscle Size, Composition, and Clinical Frailty on Long-term Outcomes Following Elective Endovascular Aneurysm Repair: a Multicenter Retrospective Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 7, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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