Major Adverse Cardiac Events After Carotid Endarterectomy

Incidence of Postoperative Major Adverse Cardiac Events in the Patients Underwent Carotid Endarterectomy: A Single Center Retrospective Study

Carotid endarterectomy is the operation for curing the significant carotid artery stenotic patients who are also at high cardiac risk. This retrospective study is to find out the incidence and risk factors related.

Study Overview

• Status: Completed
• Conditions: Carotid Stenosis; Carotid Endarterectomy; Adverse Cardiac Events

Detailed Description

The investigator plan to retrospectively investigate 175 carotid endarterectomy patients in Siriraj hospital to find the incidences of major adverse cardiac events, including

• Myocardial infarction is defined as rising of cardiac bio-markers in the setting of myocardial ischemia (Relevant anginal symptoms, ECG changes or Imaging e.g. Echocardiography)2,10
• Significant arrhythmia is defined as symptomatic or causing hemodynamic changes without other explainable causes.
• Heart failure is defined according to Modified Framingham criteria3
• Cardiac death is defined as mortality in association and as a direct result from myocardial infarction, arrhythmia or heart failure

if possible, the investigators will try to find the associate or risk factors for those events.

• Study Type: Observational
• Enrollment (Actual): 175

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10700
    • Faculty of Medicine Siriraj Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The carotid stenotic patents scheduled for carotid endarterectomy

Description

Inclusion Criteria:

• Every patients undergoing carotid endarterectomy in Siriraj hospital

Exclusion Criteria:

• Patients with other simultaneous surgery with carotid endarterectomy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse cardiac events after carotid endarterectomy	Major adverse cardiac event included myocardial infarction, significant arrhythmia, heart failure and cardiac arrest	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
associate factors with adverse cardiac event	Analysis of potential factors associated with major adverse cardiac event after carotid endarterectomy	7 days
other adverse events	respiratory complications, such as re-intubation, aspiration Neurologic complication, such as stroke length of hospital stay, ICU admission, length of ICU stay	7 days

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Aphichat Suphathamwit, M.D., Mahidol University

Publications and helpful links

General Publications

• 1. Mutirangura P et al. J Med Assoc Thai 2016; 99 (7): 785-93. 2. Boulanger M et al. Stroke. 2015 Oct;46(10):2843-8. 3. McKee PA et al. N Engl J Med. 1971 Dec 23;285(26):1441-6. 4.Go C et al. Ann Vasc Surg. 2015 Aug;29(6):1265-71. 5.Steinvil A et al. J Am Coll Cardiol. 2011 Feb 15;57(7):779-83. 6.Hoffmann R et al. Heart. 2005 Nov;91(11):1438-41. 7.Sposato LA et al. Journal of the Neurological Sciences. 2011 Oct 15;309(1-2):5-8. 8.Aboyans V et al. Eur Heart J. 2018 Mar 1;39(9):763-816. 9.Varon J, Marik PE. Vasc Health Risk Manag. 2008 Jun; 4(3): 615-627. 10.Landesberg G et al. Circulation. 2009;119:2936-2944

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: July 5, 2018
• First Submitted That Met QC Criteria: July 20, 2018
• First Posted (Actual): July 23, 2018

Study Record Updates

• Last Update Posted (Actual): January 21, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: carotid endarterectomy; adverse cardiac events
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: 2018_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No