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

NCT ID: NCT02268799

Last Updated: 2015-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

101 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation Atrial Flutter

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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DC Cardioversion

Patients undergoing DC cardioversion

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Limerick

OTHER

Sponsor Role lead

Responsible Party

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Ronstan Lobo, MB, BMedSc, MRCPI, MRCP(UK)

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas J Kiernan, MD

Role: STUDY_CHAIR

University of Limerick

Locations

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University Hospital Limerick

Dooradoyle, Limerick, Ireland

Site Status

Countries

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Ireland

Other Identifiers

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RL002

Identifier Type: -

Identifier Source: org_study_id

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