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

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ClinicalTrials.gov Identifier: NCT01258231
Recruitment Status : Recruiting
First Posted : December 10, 2010
Last Update Posted : October 4, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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

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


Condition or disease
Heart; Dysfunction Postoperative, Cardiac Surgery Genetic Predisposition to Disease Atrial Fibrillation Myocardial Infarction Heart Failure

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

Study Design

Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Genomic Predictors of Adverse Events After Cardiac Surgery
Study Start Date : August 2000
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Cardiac surgery
Adult patients undergoing cardiac surgery


Outcome Measures

Primary Outcome Measures :
  1. Atrial fibrillation [ Time Frame: 30 days ]
    Atrial fibrillation

  2. Death [ Time Frame: 5 years ]
    Death

  3. Renal dysfunction [ Time Frame: 30 days ]
    Renal dysfunction


Biospecimen Retention:   Samples With DNA
DNA, buffy coat, plasma, serum and urine

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01258231


Locations
United States, Massachusetts
Brigham and Women's Hospital Completed
Boston, Massachusetts, United States, 02115
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-9068
Contact: Amanda A Fox, MD    214-648-8018    amanda.fox@utsouthwestern.edu   
Principal Investigator: Amanda A Fox, MD         
Department Texas Heart Institute at St. Luke's Episcopal Hospital Completed
Houston, Texas, United States, 77225
Sponsors and Collaborators
Brigham and Women's Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Texas Heart Institute
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Simon C Body, MBChB, MPH Brigham and Women's Hospital
More Information

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 ( U.S. NIH Grant/Contract )
First Posted: December 10, 2010    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017

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