Echocardiography as Risk-Assessment for Major Adverse Cardiac Events in Major Vascular Surgery Patients

Completed

• Conditions: Right-Sided Heart Failure; Left-Sided Heart Failure; Heart Valve Diseases

• Registration Number: NCT04836702
• Lead Sponsor: University of Virginia

Brief Summary

Patient with coronary artery disease (CAD), heart failure and abnormal heart function undergoing major vascular surgery have a high associated high morbidity and mortality with myocardial infarction accounting for 33-50% of perioperative deaths. The prevalence of CAD in vascular surgery patients approaches 50%. Proper pre-procedure protocols to accurately assess patients and determine who may require further medical optimization prior to undergoing surgery help mitigate risk and improve outcomes. The investigators designed this study as a single center, retrospective cohort analysis to explore the association between ventricular (LV and RV function) and valvular (Aortic / Mitral / Tricuspid) function and expanded major adverse cardiac events (X-MACE).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2020-06-23
• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-05
• Study First Posted: 2021-04-08
• Study Completion: 2022-03-21
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 813

Inclusion Criteria

• Major vascular surgery operation (e.g. CEA, open aortic repair, suprainguinal and infrainguinal bypasses, EVAR, TEVAR) captured in the UVA Vascular Quality Initiative database
• Echocardiography within two years of index operation

Exclusion Criteria

• If patient had additional qualifying vascular procedure within 30 days of the index operation, this procedure was excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expanded Major Adverse Cardiac Events	In-hospital admission (within 120 days of index surgery)	Composite outcome defined as any cardiovascular death, non-fatal MI, non-fatal stroke, post-operative CHF, or new dysrhythmias, all within the index hospital admission.