Echocardiography as Risk-Assessment for Major Adverse Cardiac Events in Major Vascular Surgery Patients
NCT ID: NCT04836702
Last Updated: 2024-06-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
813 participants
OBSERVATIONAL
2011-01-01
2022-03-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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
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Inclusion Criteria
* Echocardiography within two years of index operation
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Virginia
OTHER
Responsible Party
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Margaret Clarke Tracci
Principal Investigator
Principal Investigators
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Matthew Meyer, MD
Role: STUDY_DIRECTOR
Assistant Professor of Anesthesiology at University of Virginia
References
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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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20906
Identifier Type: -
Identifier Source: org_study_id
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