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

This study is currently recruiting participants.
Verified May 2017 by Simon Body, Brigham and Women's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT00833313
First Posted: February 2, 2009
Last Update Posted: May 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Simon Body, Brigham and Women's Hospital
  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:


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

Primary Outcome Measures:
  • Gene expression [ Time Frame: Immediate ]

Biospecimen Retention:   Samples With DNA
Atrial tissue sample

Estimated Enrollment: 240
Study Start Date: August 2008
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Contact: Simon C Body, MBChB    617-732-7330    sbody@bwh.harvard.edu   
Sub-Investigator: Jochen D Muehlschlegel, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Simon C Body, MD Brigham and Women's Hospital
  More Information

Responsible Party: Simon Body, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00833313     History of Changes
Other Study ID Numbers: 2008-P000896
First Submitted: January 5, 2009
First Posted: February 2, 2009
Last Update Posted: May 16, 2017
Last Verified: May 2017

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

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