- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00590525
Inflammation as a Predictor in Cardioversion of Atrial Fibrillation
November 27, 2009 updated by: Creighton University
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
45
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nebraska
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Omaha, Nebraska, United States, 68131
- Creighton University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Consecutive patients undergoing DC cardioversion at The Cardiac Center electrophysiology lab who meet these criteria will be enrolled.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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1
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
We hypothesize that a higher hsCRP is associated with higher failure rates in patients undergoing cardioversion for atrial fibrillation
Time Frame: 1 month
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1 month
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
secondary endpoint will be if a new inflammatory disease state is diagnosed at the one-month mark.
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Susan Schima, MD, Creighton University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
December 28, 2007
First Submitted That Met QC Criteria
January 9, 2008
First Posted (Estimate)
January 10, 2008
Study Record Updates
Last Update Posted (Estimate)
December 1, 2009
Last Update Submitted That Met QC Criteria
November 27, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-13547
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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