NCT00590525

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2004

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 10, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

December 1, 2009

Status Verified

November 1, 2009

Enrollment Period

4.7 years

First QC Date

December 28, 2007

Last Update Submit

November 27, 2009

Conditions

Atrial Fibrillation

Keywords

hsCRP

Outcome Measures

Primary Outcomes (1)

  • We hypothesize that a higher hsCRP is associated with higher failure rates in patients undergoing cardioversion for atrial fibrillation

    1 month

Secondary Outcomes (1)

  • secondary endpoint will be if a new inflammatory disease state is diagnosed at the one-month mark.

    1 month

Study Arms (1)

1

Procedure: Cardioversion

Interventions

CardioversionPROCEDURE

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

1

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Atrial fibrillation patients referred for DC cardioversion
  • On stable medical therapy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Electric Countershock

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Study Officials

  • Susan Schima, MD

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 28, 2007

First Posted

January 10, 2008

Study Start

October 1, 2004

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

December 1, 2009

Record last verified: 2009-11

Locations

US(1)