Major Adverse Cardiac Events After Carotid Endarterectomy

Carotid Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03596229
• Other study ID #: 2018_1
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: January 15, 2020

Study information

• Verified date: January 2020
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: January 15, 2020
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Every patients undergoing carotid endarterectomy in Siriraj hospital

Exclusion Criteria:

• Patients with other simultaneous surgery with carotid endarterectomy

Related Conditions & MeSH terms

• Adverse Cardiac Events
• Carotid Endarterectomy
• Carotid Stenosis

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	associate factors with adverse cardiac event	Analysis of potential factors associated with major adverse cardiac event after carotid endarterectomy	7 days
Secondary	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