Identification of Genomic Predictors of Adverse Events After Cardiac Surgery - Full Text View

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

This study is currently recruiting participants.

Verified May 2012 by Brigham and Women's Hospital

First Received on December 9, 2010. Last Updated on May 14, 2012 History of Changes

Sponsor:	Brigham and Women's Hospital
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

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	Intervention
Heart Surgery Genetics Atrial Fibrillation Myocardial Infarction Heart Failure	Device: Transesophageal echocardiography

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:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome Help Me Understand Genetics

MedlinePlus related topics: Atrial Fibrillation Heart Attack Heart Failure Heart Surgery

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	Assigned Interventions
Adult patients undergoing cardiac surgery	Device: Transesophageal echocardiography Data from routinely performed transesophageal echocardiography are collected

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

Responsible Party:	Simon Body, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT01258231 History of Changes
Other Study ID Numbers:	2000P001639
Study First Received:	December 9, 2010
Last Updated:	May 14, 2012
Health Authority:	USA: CABG Genomics Data Safety and Monitoring Board

Additional relevant MeSH terms:

Atrial Fibrillation
Heart Failure
Infarction
Myocardial Infarction
Arrhythmias, Cardiac
Heart Diseases

Cardiovascular Diseases
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2012