NCT02268799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

10 months

First QC Date

October 15, 2014

Last Update Submit

August 12, 2015

Conditions

Atrial FibrillationAtrial Flutter

Keywords

CardioversionHigh Sensitivity Troponin T (Hs-Trop T)Brain Natriuretic Peptide (BNP)Neutrophil Gelatinase-associated Lipocalin (NGAL)

Outcome Measures

Primary Outcomes (1)

  • High Sensitivity Troponin T levels pre and 6 hours post cardioversion

    1 year

Secondary Outcomes (3)

  • 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

Study Arms (1)

DC Cardioversion

Patients undergoing DC cardioversion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patients with atrial fibrillation / atrial flutter attending for direct current external cardioversion
  • Age 18 or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Limerick

Dooradoyle, Limerick, Ireland

Location

MeSH Terms

Conditions

Atrial FibrillationAtrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas J Kiernan, MD

    University of Limerick

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 15, 2014

First Posted

October 20, 2014

Study Start

October 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

IE(1)