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Gene Expression Profiling in Subjects With Postoperative Atrial Fibrillation After Cardiac Surgery

This study is currently recruiting participants.
Verified December 2012 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Simon Body, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00833313
First received: January 5, 2009
Last updated: December 31, 2012
Last verified: December 2012
History of Changes
  Purpose

Atrial fibrillation is a type of irregular heartbeat that is common after having heart surgery. There may be many different reasons why some people get atrial fibrillation after their heart surgery. These reasons may include that a person is older or that he/she is taking certain types of medications before surgery. Genes may also be a reason. Genes contain the material passed from parent to child that determines the make-up of the body and mind. For example, some genes control the color of your hair or eyes. Some people may have genes that make it more likely for them to get atrial fibrillation after their heart surgery. This research project is being done to find out if the cells of people who develop atrial fibrillation after heart surgery are different from the cells in people who do not develop atrial fibrillation after surgery.


Condition Intervention
Atrial Fibrillation
 Other: Atrial biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gene Expression Profiling in Subjects With Postoperative Atrial Fibrillation After Cardiac Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Gene expression [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Atrial tissue sample


Estimated Enrollment: 240
Study Start Date: August 2008
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Atrial biopsy
    Biopsy of right atrial free wall
Detailed Description:

Atrial fibrillation is a type of irregular heartbeat that is common after having heart surgery. There may be many different reasons why some people get atrial fibrillation after their heart surgery. These reasons may include that a person is older or that he/she is taking certain types of medications before surgery. Genes may also be a reason. Genes contain the material passed from parent to child that determines the make-up of the body and mind. For example, some genes control the color of your hair or eyes. Some people may have genes that make it more likely for them to get atrial fibrillation after their heart surgery. This research project is being done to find out if the cells of people who develop atrial fibrillation after heart surgery are different from the cells in people who do not develop atrial fibrillation after surgery.

This study seeks to identify regulatory events in atrial myocyte transcription and translation that are altered by germline variation

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients undergoing cardiac surgery

Criteria

Inclusion Criteria:

  • Age 20-80 years
  • Undergoing cardiac surgery

Exclusion Criteria:

  • Prior atrial fibrillation or flutter
  • Taking Amiodarone
  • Taking Sotalol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833313

Contacts
Contact: Simon C Body, MD 617-732-7330 sbody@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Simon C Body, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Simon Body, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00833313     History of Changes
Other Study ID Numbers: 2008-P000896
Study First Received: January 5, 2009
Last Updated: December 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Atrial fibrillation
Gene expression
Genetic

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013