Inflammation as a Predictor in Cardioversion of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Inflammation as a Predictor in Cardioversion of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590525
• Other study ID #: 04-13547
• Secondary ID: 04-13547
• Status: Completed
• Phase: N/A
• First received: December 28, 2007
• Last updated: November 27, 2009
• Start date: October 2004
• Est. completion date: June 2009

Study information

• Verified date: November 2009
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
United States	Creighton University Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	We hypothesize that a higher hsCRP is associated with higher failure rates in patients undergoing cardioversion for atrial fibrillation		1 month	Yes
Secondary	secondary endpoint will be if a new inflammatory disease state is diagnosed at the one-month mark.		1 month	Yes