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

Sponsor
University of Virginia (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04836702
Collaborator
(none)
800
128

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Vascular Surgery Outcomes: Echocardiography as Risk-Assessment for Major Adverse Cardiac Events in Major Vascular Surgery Patients
    Actual Study Start Date :
    Jan 1, 2011
    Actual Primary Completion Date :
    Jun 23, 2020
    Anticipated Study Completion Date :
    Sep 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Left ventricular function

    Depressed LV function LV ejection fraction < 50% LV systolic function; defined as mild / mod / sev decreased LV diastolic function; defined as mild (g1 ) / mod (g2) / sev ( g3) decreased Normal LV function

    Right ventricular function

    Depressed RV function a. RV systolic function defined as mild / mod / sev decreased Normal RV function

    Valvular lesions

    Moderate or severe valvular lesions Aortic stenosis Aortic regurgitation Mitral stenosis Mitral regurgitation Tricuspid regurgitation Clinically normal valvular lesions No valvular lesion Mild stenosis / regurgitation of above mentioned lesions

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Virginia

    Investigators

    • Study Director: Matthew Meyer, MD, Assistant Professor of Anesthesiology at University of Virginia

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    University of Virginia
    ClinicalTrials.gov Identifier:
    NCT04836702
    Other Study ID Numbers:
    • 20906
    First Posted:
    Apr 8, 2021
    Last Update Posted:
    Apr 8, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Virginia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 8, 2021