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Trial record 29 of 48 for:    Recruiting, Not yet recruiting, Available Studies | "Carotid Stenosis"

Major Adverse Cardiac Events After Carotid Endarterectomy

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ClinicalTrials.gov Identifier: NCT03596229
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Aphichat Suphathamwit,, Mahidol University

Brief 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.

Condition or disease
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.


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Study Type : Observational
Estimated Enrollment : 175 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence of Postoperative Major Adverse Cardiac Events in the Patients Underwent Carotid Endarterectomy: A Single Center Retrospective Study
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 30, 2019



Primary Outcome Measures :
  1. Incidence of major adverse cardiac events after carotid endarterectomy [ Time Frame: 7 days ]
    Major adverse cardiac event included myocardial infarction, significant arrhythmia, heart failure and cardiac arrest


Secondary Outcome Measures :
  1. associate factors with adverse cardiac event [ Time Frame: 7 days ]
    Analysis of potential factors associated with major adverse cardiac event after carotid endarterectomy

  2. other adverse events [ Time Frame: 7 days ]
    respiratory complications, such as re-intubation, aspiration Neurologic complication, such as stroke length of hospital stay, ICU admission, length of ICU stay



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The carotid stenotic patents scheduled for carotid endarterectomy
Criteria

Inclusion Criteria:

  • Every patients undergoing carotid endarterectomy in Siriraj hospital

Exclusion Criteria:

  • Patients with other simultaneous surgery with carotid endarterectomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596229


Contacts
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Contact: Aphichat Suphathamwit, M.D. 66982786069 aphichat.suh@mahidol.ac.th

Locations
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Thailand
Faculty of Medicine Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Aphichat Suphathamwit, MD    66982786069    aphichatsup99@gmail.com   
Principal Investigator: Aphichat Suphathamwit, MD         
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Aphichat Suphathamwit, M.D. Mahidol University

Publications of Results:
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

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Responsible Party: Aphichat Suphathamwit,, Lecturer, Mahidol University
ClinicalTrials.gov Identifier: NCT03596229     History of Changes
Other Study ID Numbers: 2018_1
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aphichat Suphathamwit,, Mahidol University:
carotid endarterectomy
adverse cardiac events

Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases