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

NCT ID: NCT04836702

Last Updated: 2024-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

813 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2022-03-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Left-Sided Heart Failure Right-Sided Heart Failure Heart Valve Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Right ventricular function

* Depressed RV function

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Margaret Clarke Tracci

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matthew Meyer, MD

Role: STUDY_DIRECTOR

Assistant Professor of Anesthesiology at University of Virginia

References

Explore related publications, articles, or registry entries linked to this study.

Reis PV, Lopes AI, Leite D, Moreira J, Mendes L, Ferraz S, Amaral T, Mourao J, Abelha F. Major Cardiac Events in Patients Admitted to Intensive Care After Vascular Noncardiac Surgery: A Retrospective Cohort. Semin Cardiothorac Vasc Anesth. 2019 Sep;23(3):293-299. doi: 10.1177/1089253218825442. Epub 2019 Jan 25.

Reference Type BACKGROUND
PMID: 30678531 (View on PubMed)

Golubovic M, Peric V, Stanojevic D, Lazarevic M, Jovanovic N, Ilic N, Djordjevic M, Kostic T, Milic D. Potential New Approaches in Predicting Adverse Cardiac Events One Month after Major Vascular Surgery. Med Princ Pract. 2019;28(1):63-69. doi: 10.1159/000495079. Epub 2018 Nov 4.

Reference Type BACKGROUND
PMID: 30391950 (View on PubMed)

Ouriel K, Green RM, DeWeese JA, Varon ME. Outpatient echocardiography as a predictor of perioperative cardiac morbidity after peripheral vascular surgical procedures. J Vasc Surg. 1995 Dec;22(6):671-7; discussion 678-9. doi: 10.1016/s0741-5214(95)70057-9.

Reference Type BACKGROUND
PMID: 8523601 (View on PubMed)

Flu WJ, van Kuijk JP, Hoeks SE, Kuiper R, Schouten O, Goei D, Elhendy A, Verhagen HJ, Thomson IR, Bax JJ, Fleisher LA, Poldermans D. Prognostic implications of asymptomatic left ventricular dysfunction in patients undergoing vascular surgery. Anesthesiology. 2010 Jun;112(6):1316-24. doi: 10.1097/ALN.0b013e3181da89ca.

Reference Type BACKGROUND
PMID: 20502115 (View on PubMed)

Lerman BJ, Popat RA, Assimes TL, Heidenreich PA, Wren SM. Association of Left Ventricular Ejection Fraction and Symptoms With Mortality After Elective Noncardiac Surgery Among Patients With Heart Failure. JAMA. 2019 Feb 12;321(6):572-579. doi: 10.1001/jama.2019.0156.

Reference Type BACKGROUND
PMID: 30747965 (View on PubMed)

Matyal R, Hess PE, Subramaniam B, Mitchell J, Panzica PJ, Pomposelli F, Mahmood F. Perioperative diastolic dysfunction during vascular surgery and its association with postoperative outcome. J Vasc Surg. 2009 Jul;50(1):70-6. doi: 10.1016/j.jvs.2008.12.032.

Reference Type BACKGROUND
PMID: 19563954 (View on PubMed)

Meyer MJ, Jameson SA, Gillig EJ, Aggarwal A, Ratcliffe SJ, Baldwin M, Singh KE, Clouse WD, Blank RS. Clinical implications of preoperative echocardiographic findings on cardiovascular outcomes following vascular surgery: An observational trial. PLoS One. 2023 Jan 19;18(1):e0280531. doi: 10.1371/journal.pone.0280531. eCollection 2023.

Reference Type DERIVED
PMID: 36656845 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20906

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.