Inflammation as a Predictor in Cardioversion of Atrial Fi... | NCT00590525

Studies
Inflammation as a Predictor in Cardioversion of Atrial Fibrillation

NCT00590525

Sponsor

Creighton University

Status

Completed

Last Update Posted

Dec 1, 2009Estimated

Enrollment

45Actual

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

Cardioversion

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
04-13547

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2004

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Dec 28, 2007

First Submission Date that Met QC Criteria

Jan 9, 2008

First Posted Date

Jan 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2009

Last Update Posted Date

Dec 1, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1			Procedure: Cardioversion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardioversion	Procedure	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
We hypothesize that a higher hsCRP is associated with higher failure rates in patients undergoing cardioversion for atrial fibrillation		1 month

Secondary Outcomes

Measure	Description	Time Frame
secondary endpoint will be if a new inflammatory disease state is diagnosed at the one-month mark.		1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan Schima, MD	Creighton University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Creighton University Medical Center		Omaha	Nebraska	68131	United States

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004554	Electric Countershock

Ancestor Terms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided