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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03596229
Other study ID # 2018_1
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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