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

June 11, 2024 updated by: Margaret Clarke Tracci, University of Virginia

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

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

813

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent major vascular surgery operations at the University of Virginia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Left ventricular function

  • Depressed LV function

    1. LV ejection fraction < 50%
    2. LV systolic function; defined as mild / mod / sev decreased
    3. 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

    1. Aortic stenosis
    2. Aortic regurgitation
    3. Mitral stenosis
    4. Mitral regurgitation
    5. Tricuspid regurgitation

  • Clinically normal valvular lesions

    1. No valvular lesion
    2. Mild stenosis / regurgitation of above mentioned lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expanded Major Adverse Cardiac Events
Time Frame: 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.
In-hospital admission (within 120 days of index surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

June 23, 2020

Study Completion (Actual)

March 21, 2022

Study Registration Dates

First Submitted

April 1, 2021

First Submitted That Met QC Criteria

April 5, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20906

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Will be made on an individual basis in accordance with guidance from the IRB and VQI panel

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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