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

August 12, 2015 updated by: Ronstan Lobo, MB, BMedSc, MRCPI, MRCP(UK), University of Limerick

High Sensitivity Troponin T Levels Following Elective External Direct Current 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
    • Limerick
      • Dooradoyle, Limerick, Ireland
        • University Hospital Limerick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with atrial fibrillation/flutter who attend the Coronary Care Unit of the University Hospital Limerick for a pre-organised appointment for direct current external cardioversion will be requested to participate in the study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
DC Cardioversion
Patients undergoing DC cardioversion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
High Sensitivity Troponin T levels pre and 6 hours post cardioversion
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Limerick

Investigators

  • Study Chair: Thomas J Kiernan, MD, University of Limerick

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

October 15, 2014

First Submitted That Met QC Criteria

October 17, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 12, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RL002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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