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Identification of Genomic Predictors of Adverse Events After Cardiac Surgery (CABG Genomics)

This study is currently recruiting participants.
Verified December 2012 by Brigham and Women's Hospital
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Texas Heart Institute
Information provided by (Responsible Party):
Simon Body, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01258231
First received: December 9, 2010
Last updated: December 31, 2012
Last verified: December 2012
History of Changes
  Purpose

This study aims to identify genetic causes of adverse events after cardiac surgery, such as atrial fibrillation, myocardial infarction and heart failure.

Patients undergoing heart surgery at Brigham and Women's Hospital and Texas Heart Institute are eligible to participate


Condition
Heart Surgery
Genetics
Atrial Fibrillation
Myocardial Infarction
Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Genomic Predictors of Adverse Events 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:
  • Atrial fibrillation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Atrial fibrillation

  • Myocardial infarction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Myocardial infarction

  • Heart failure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Heart failure


Biospecimen Retention:   Samples With DNA

DNA, buffy coat, plasma and serun


Estimated Enrollment: 4000
Study Start Date: August 2000
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: August 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adult patients undergoing cardiac surgery

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients undergoing heart surgery

Criteria

Inclusion Criteria:

  • Undergoing heart surgery
  • Willing to provide consent

Exclusion Criteria:

  • Enrolled in a concurrent drug or device trial that precludes concurrent enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258231

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Simon C Body, MBChB, MPH     617-732-7330     body@zeus.bwh.harvard.edu    
Principal Investigator: Simon C Body, MBChB, MPH            
United States, Texas
Department Texas Heart Institute at St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States, 77225
Contact: Charles D Collard, MD     832-355-4615        
Principal Investigator: Charles D Collard, MD            
Sponsors and Collaborators
Brigham and Women's Hospital
National Institutes of Health (NIH)
Texas Heart Institute
Investigators
Principal Investigator: Simon C Body, MBChB, MPH Brigham and Women's Hospital
  More Information

No publications provided by Brigham and Women's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Simon Body, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01258231     History of Changes
Obsolete Identifiers: NCT00281164
Other Study ID Numbers: 2000P001639
Study First Received: December 9, 2010
Last Updated: December 31, 2012
Health Authority: USA: CABG Genomics Data Safety and Monitoring Board

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Failure
Infarction
Myocardial Infarction
Heart Diseases
 Cardiovascular Diseases
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013