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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 : September 20, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Texas Heart Institute
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital

December 9, 2010
December 10, 2010
September 20, 2018
August 2000
August 2030   (Final data collection date for primary outcome measure)
Mortality (i.e. number of participants who are deceased during postoperative day 0 up to year 5) [ Time Frame: Day of procedure to year 5 ]
Data will be collected from electronic medical records; data points to be collected for this measurement include serum creatinine.
  • Atrial fibrillation
    Atrial fibrillation
  • Myocardial infarction
    Myocardial infarction
  • Heart failure
    Heart failure
Complete list of historical versions of study NCT01258231 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • Acute Kidney Injury using KDIGO criteria: albumin/creatinine ratio (>/= 300 mg/g) and eGRF (< 60 mL/min/1.73^2) [ Time Frame: Day of procedure to post procedure day 7 ]
    Data will be collected from electronic medical records; data points to be collected for this measurement include serum creatinine.
  • Presence of Arrhythmia (i.e. number of patients who develop an arrhythmia after their cardiac surgery) [ Time Frame: Day of procedure to year 5 ]
    Data will be collected from electronic medical records; data points to be collected for this measurement include post-procedural EKG reports and progress notes.
  • Myocardial Infarction (i.e. number of participants who develop a MI during postoperative day 0 to year 5) [ Time Frame: Day of procedure to year 5 ]
    Data will be collected from electronic medical records; data points to be collected for this measurement include post-procedural EKG reports, cardiac enzyme values, progress notes, and cardiac catheterization reports.
  • Heart failure per NYHA class II, III, IV [ Time Frame: Day of procedure to year 5 ]
    This will be measured in accordance to New York Heart Association Guidelines.
  • Quality of Life Survey - The Kansas City Cardiomyopathy Questionnaire (KCCQShortForm) [ Time Frame: Administered once prior to the procedure and 1 month to 5 years after hospital discharge ]
    A questionnaire to assess for heart failure
  • Quality of Life Survey - The Seattle Angina Questionnaire (SAQShortForm) [ Time Frame: Administered once prior to the procedure and 1 month to 5 years after hospital discharge ]
    A questionnaire to assess for angina
  • Quality of Life Survey - 12-item short form health survey (SF12) [ Time Frame: Administered once prior to the procedure and 1 month to 5 years after hospital discharge ]
    A questionnaire to assess for overall health
Not Provided
 
Identification of Genomic Predictors of Adverse Events After Cardiac Surgery
Identification of Genomic Predictors of Adverse Events After Cardiac Surgery

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.

This study aims to identify genetic causes of adverse events after cardiac surgery, such as atrial fibrillation, myocardial infarction, renal dysfunction and heart failure.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
DNA, buffy coat, plasma, serum and urine
Non-Probability Sample
Adult patients undergoing heart surgery
  • Heart; Dysfunction Postoperative, Cardiac Surgery
  • Genetic Predisposition to Disease
  • Atrial Fibrillation
  • Myocardial Infarction
  • Heart Failure
Not Provided
Cardiac surgery
Adult patients undergoing cardiac surgery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4000
Same as current
August 2030
August 2030   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Undergoing heart surgery
  • Willing to provide consent

Exclusion Criteria:

  • Enrolled in a concurrent drug or device trial that precludes concurrent enrollment
Sexes Eligible for Study: All
20 Years to 90 Years   (Adult, Older Adult)
No
United States
 
 
NCT01258231
2000P001639
5R01HL098601 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Texas Heart Institute
  • University of Texas Southwestern Medical Center
Principal Investigator: Simon C Body, MBChB, MPH Brigham and Women's Hospital
Brigham and Women's Hospital
September 2018