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

This study is currently recruiting participants.
Verified May 2017 by Simon Body, Brigham and Women's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01258231
First Posted: December 10, 2010
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.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Texas Heart Institute
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Simon Body, Brigham and Women's Hospital
  Purpose

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
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 Simon Body, Brigham and Women's Hospital:

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

  • Death [ Time Frame: 5 years ]
    Death

  • Renal dysfunction [ Time Frame: 30 days ]
    Renal dysfunction


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, renal dysfunction and heart failure.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 Recruiting
Boston, Massachusetts, United States, 02115
Contact: Simon C Body, MBChB, MPH    617-732-7330    sbody@bwh.harvard.edu   
Principal Investigator: Simon C Body, MBChB, MPH         
Sub-Investigator: Jochen D Muehlschlegel, MD         
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 Recruiting
Houston, Texas, United States, 77225
Contact: Charles D Collard, MD    832-355-4615    ccollard@heart.thi.tmc.edu   
Principal Investigator: Charles D Collard, MD         
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 Submitted: December 9, 2010
First Posted: December 10, 2010
Last Update Posted: May 16, 2017
Last Verified: May 2017

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


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