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

Completed

• Conditions: Atrial Fibrillation; Atrial Flutter

• Registration Number: NCT02268799
• Lead Sponsor: University of Limerick

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-10-17
• Study First Posted: 2014-10-20
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-12
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
High Sensitivity Troponin T levels pre and 6 hours post cardioversion	1 year

Secondary Outcome Measures

Name	Time	Method
Creatine Kinase levels pre and 6 hours post cardioversion	1 year
B-type Natriuretic Peptide (BNP) levels pre and 6 hours post cardioversion	1 year
Neutrophil Gelatinase-associated Lipocalin (NGAL) levels pre and 6 hours post cardioversion	1 year

Trial Locations

Locations (1)

University Hospital Limerick; 🇮🇪 Dooradoyle, Limerick, Ireland