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

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.
 
ClinicalTrials.gov Identifier: NCT01258231
Recruitment Status : Recruiting
First Posted : December 10, 2010
Last Update Posted : February 8, 2023
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

Tracking Information
First Submitted Date December 9, 2010
First Posted Date December 10, 2010
Last Update Posted Date February 8, 2023
Actual Study Start Date August 2000
Estimated Primary Completion Date August 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 2018)		 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.
Original Primary Outcome Measures
 (submitted: December 9, 2010)
  • Atrial fibrillation
    Atrial fibrillation
  • Myocardial infarction
    Myocardial infarction
  • Heart failure
    Heart failure
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: September 18, 2018)
  • 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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Identification of Genomic Predictors of Adverse Events After Cardiac Surgery
Official Title Identification of Genomic Predictors of Adverse Events After Cardiac Surgery
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.
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. In addition, we also examine blood and urine biomarkers (proteins).
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
DNA, buffy coat, plasma, serum and urine
Sampling Method Non-Probability Sample
Study Population Adult patients undergoing heart surgery
Condition
  • Heart; Dysfunction Postoperative, Cardiac Surgery
  • Genetic Predisposition to Disease
  • Atrial Fibrillation
  • Myocardial Infarction
  • Heart Failure
Intervention Not Provided
Study Groups/Cohorts Cardiac surgery
Adult patients undergoing cardiac surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 9, 2010)		 4000
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 2030
Estimated Primary Completion Date August 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Undergoing heart surgery
  • Willing to provide consent

Exclusion Criteria:

  • Enrolled in a concurrent drug or device trial that precludes concurrent enrollment
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01258231
Other Study ID Numbers 2000P001639
5R01HL098601 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital
Original Responsible Party Simon C Body, MBChB, MPH, Partners Healthcare
Current Study Sponsor Brigham and Women's Hospital
Original Study Sponsor Same as current
Collaborators
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Texas Heart Institute
  • University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Jochen D Muehlschlegel, MD MMSc, MPH Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date February 2023