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Completed

NCT Number: NCT03596229

Major Adverse Cardiac Events After Carotid Endarterectomy

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.

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Key information

Conditions

Carotid Stenosis Adverse Cardiac Events Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Endarterectomy Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine Siriraj Hospital

Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Every patients undergoing carotid endarterectomy in Siriraj hospital

Exclusion criteria

  • Patients with other simultaneous surgery with carotid endarterectomy

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 23, 2018
Registry last updated
Jan 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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