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CABGGenomics: Identification of Genomic Predictors of Adverse Events After Cardiac Surgery

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT01258231
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH), Texas Heart Institute (Other), University of Texas Southwestern Medical Center (Other)
4,000
Enrollment
3
Locations
360
Duration (Months)
1333.3
Patients Per Site
3.7
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    4000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Identification of Genomic Predictors of Adverse Events After Cardiac Surgery
    Study Start Date :
    Aug 1, 2000
    Anticipated Primary Completion Date :
    Aug 1, 2030
    Anticipated Study Completion Date :
    Aug 1, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    Cardiac surgery

    Adult patients undergoing cardiac surgery

    Outcome Measures

    Primary Outcome Measures

    1. Mortality (i.e. number of participants who are deceased during postoperative day 0 up to year 5) [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) [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) [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) [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 [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) [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) [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) [Administered once prior to the procedure and 1 month to 5 years after hospital discharge]

      A questionnaire to assess for overall health

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Brigham and Women's Hospital Boston Massachusetts United States 02115
    2 UT Southwestern Medical Center Dallas Texas United States 75390-9068
    3 Department Texas Heart Institute at St. Luke's Episcopal Hospital 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

    • Principal Investigator: Jochen D Muehlschlegel, MD MMSc, MPH, Brigham and Women's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jochen Daniel Muehlschlegel, MD, Associate Professor, Brigham and Women's Hospital
    ClinicalTrials.gov Identifier:
    NCT01258231
    Other Study ID Numbers:
    • 2000P001639
    • 5R01HL098601
    • NCT00281164
    First Posted:
    Dec 10, 2010
    Last Update Posted:
    May 11, 2021
    Last Verified:
    May 1, 2021
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Myocardial Infarction
    Infarction
    Disease Susceptibility
    Genetic Predisposition to Disease

    Study Results

    No Results Posted as of May 11, 2021