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Completed

NCT Number: NCT02268799

High Sensitivity Troponin T Levels Following DC Cardioversion for Atrial Fibrillation / Atrial Flutter

The purpose of this study is to determine if there is a rise in serum high sensitivity troponin T (a marker for heart muscle injury) following a direct current cardioversion (shock therapy) used for patients with atrial fibrillation. This will help us determine if direct current cardioversion results in damage to the heart muscles in a sufficient amount to cause a rise in high sensitivity troponin T.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Limerick

Dooradoyle, Limerick, Ireland

About this study

High sensitivity Troponin T is a relatively new biomarker that is highly sensitive and specific for myocardial injury. Its widespread use has helped in the determination and investigation for myocardial ischemia in patients. Previous studies have shown a rise in creatine kinase (CK) and the more specific creatine kinase-MB isoenzyme (CKMB) after DC cardioversion. Studies on the earlier generation troponin T found that the levels don't rise or rise only minimally after DC cardioversion. The high sensitivity troponin T has never been studied in the setting of DC cardioversion.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with atrial fibrillation / atrial flutter attending for direct current external cardioversion
  • Age 18 or older

Exclusion criteria

  • Myocardial infarction within the last 6 weeks
  • Coronary artery bypass grafting, percutaneous coronary intervention or any other invasive cardiac procedure within the last 6 weeks

Treatment and study plan

Primary outcomes

  1. High Sensitivity Troponin T levels pre and 6 hours post cardioversion

    Time frame: 1 year

Secondary outcomes

  1. Creatine Kinase levels pre and 6 hours post cardioversion

    Time frame: 1 year

  2. B-type Natriuretic Peptide (BNP) levels pre and 6 hours post cardioversion

    Time frame: 1 year

  3. Neutrophil Gelatinase-associated Lipocalin (NGAL) levels pre and 6 hours post cardioversion

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Limerick

Other

Registry information

Official study title

High Sensitivity Troponin T Levels Following Elective External Direct Current Cardioversion for Atrial Fibrillation / Atrial Flutter

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 20, 2014
Registry last updated
Aug 13, 2015

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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