Inflammation as a Predictor in Cardioversion of Atrial Fibrillation - Full Text View

Sponsored by:	Creighton University
Information provided by:	Creighton University
ClinicalTrials.gov Identifier:	NCT00590525

Purpose

The laboratory test, C-Reactive Protein (CRP), has become well established as a marker of inflammation. Recently a high CRP level (indicating an increase in inflammation) was identified as a risk factor for atrial fibrillation. We are conducting this study with patients such as yourself with atrial fibrillation who are planning to undergo cardioversion to determine what sort of relationship exists between CRP levels and atrial fibrillation.

We will then look at success rates of converting atrial fibrillation to normal sinus rhythm, compared to patients' CRP levels.

Condition	Intervention
Atrial Fibrillation	Procedure: Cardioversion

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Further study details as provided by Creighton University:

Primary Outcome Measures:

We hypothesize that a higher hsCRP is associated with higher failure rates in patients undergoing cardioversion for atrial fibrillation [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

secondary endpoint will be if a new inflammatory disease state is diagnosed at the one-month mark. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	October 2004
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1	Procedure: Cardioversion Baseline hsCRP will be drawn the morning of, prior to, cardioversion. An EKG to document the patient's rhythm will be obtained at the one-month mark

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Consecutive patients undergoing DC cardioversion at The Cardiac Center electrophysiology lab who meet these criteria will be enrolled.

Criteria

Inclusion Criteria

Atrial fibrillation patients referred for DC cardioversion
On stable medical therapy Exclusion Criteria
Known chronic inflammatory states such as infections, rheumatoid arthritis or known vasculitides.
Patients having undergone recent surgery or who are on steroid therapy for any reason will be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590525

Contacts

Contact: Susan Schima, MD

402-280-4292

susan.schima@cardiac.creighton.edu

Locations

United States, Nebraska
Creighton University Medical Center	Recruiting
Omaha, Nebraska, United States, 68131
Contact: Susan Schima, MD 402-280-4292 Susan.Schima@cardiac.creighton.edu

Sponsors and Collaborators

Creighton University

Investigators

Principal Investigator:

Susan Schima, MD

Creighton University

More Information

No publications provided

Responsible Party:	Creighton University ( Susan Schima, MD )
Study ID Numbers:	04-13547, 04-13547
Study First Received:	December 28, 2007
Last Updated:	April 16, 2009
ClinicalTrials.gov Identifier:	NCT00590525 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Creighton University:

hsCRP

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009