Identification of Genomic Predictors of Adverse Events After Cardiac Surgery (CABGGenomics)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Brigham and Women's Hospital
Sponsor:
Collaborators:
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: July 29, 2013
Last verified: July 2013
  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; Dysfunction Postoperative, Cardiac Surgery
Genetic Predisposition to Disease
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:


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


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
Cardiac surgery
Adult patients undergoing cardiac surgery

Detailed Description:

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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, 5R01HL098601
Study First Received: December 9, 2010
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Arrhythmias, Cardiac
Heart Diseases
Myocardial Ischemia
Atrial Fibrillation
Disease Susceptibility
Genetic Predisposition to Disease
Cardiovascular Diseases
Pathologic Processes
Disease Attributes
Ischemia
Necrosis
Vascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014