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

Heart Valve Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04836702
• Other study ID #: 20906
• Status: Active, not recruiting
• Start date: January 1, 2011
• Est. completion date: September 2021

Study information

• Verified date: April 2021
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: September 2021
• Est. primary completion date: June 23, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Reis PV, Lopes AI, Leite D, Moreira J, Mendes L, Ferraz S, Amaral T, Mourão 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expanded Major Adverse Cardiac Events	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)