NCT00321282

Brief Summary

Roughly thirty percent of people that undergo open heart surgery get an abnormal heart beat afterwards known as atrial fibrillation (AF). While not life threatening, this abnormal heart beat increases the likelihood of stroke and delays recovery. There are strategies to prevent post-operative AF, but they are costly and sometimes have undesirable side effects. Therefore, it would be best if we use these preventive treatments only in high risk patients. We intend to develop a risk prediction model based on demographic and electrocardiogram (ECG) findings that will predicted who is likely to get AF. We will develop this model using data already available on patients who have undergone cardiac surgery. The development of this model will use the latest mathematical algorithms similar to those used to study genetic evolution. This type of model is capable of looking at many parameters in an unbiased way, so that only the strongest, independent predictors remain in the final model. Once, the model is developed, we will validate the model by comparing our predictions to actual outcomes previously recorded in the database.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

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

February 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

September 27, 2013

Status Verified

September 1, 2013

Enrollment Period

1.4 years

First QC Date

May 1, 2006

Last Update Submit

September 26, 2013

Conditions

Coronary Artery Bypass

Keywords

Atrial FibrillationCoronary Artery Bypass GraftRisk Stratification

Interventions

Atrial FibrillationPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To prevent post-operative atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Crawford Long Hospital

Atlanta, Georgia, 30365, United States

Location

Veterans Administration Medical Center

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Samuel C. Dudley, Jr., MD, PhD

    Atlanta VAMC/Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 1, 2006

First Posted

May 3, 2006

Study Start

February 1, 2006

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

September 27, 2013

Record last verified: 2013-09

Locations

US(3)