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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02268799
• Other study ID #: RL002
• Status: Completed
• Phase: N/A
• First received: October 15, 2014
• Last updated: August 12, 2015
• Start date: October 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: University of Limerick
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Locations

Country	Name	City	State
Ireland	University Hospital Limerick	Dooradoyle	Limerick

Sponsors (1)

Lead Sponsor	Collaborator
University of Limerick

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High Sensitivity Troponin T levels pre and 6 hours post cardioversion		1 year	No
Secondary	Creatine Kinase levels pre and 6 hours post cardioversion		1 year	No
Secondary	B-type Natriuretic Peptide (BNP) levels pre and 6 hours post cardioversion		1 year	No
Secondary	Neutrophil Gelatinase-associated Lipocalin (NGAL) levels pre and 6 hours post cardioversion		1 year	No