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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

Study Description
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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. In addition, we also examine blood and urine biomarkers (proteins).
Study Design
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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
Actual Study Start Date : August 2000
Estimated Primary Completion Date : August 2030
Estimated Study Completion Date : August 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Groups and Cohorts
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Group/Cohort
Cardiac surgery
Adult patients undergoing cardiac surgery


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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


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

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
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
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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
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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
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Principal Investigator: Jochen D Muehlschlegel, MD MMSc, MPH Brigham and Women's Hospital
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jochen Daniel Muehlschlegel, MD, Associate Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01258231    
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: February 8, 2023
Last Verified: February 2023
Additional relevant MeSH terms:
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Atrial Fibrillation
Myocardial Infarction
Infarction
Genetic Predisposition to Disease
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
 Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Vascular Diseases
Disease Susceptibility
Disease Attributes