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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02268799
Other study ID # RL002
Secondary ID
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


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
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