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NCT Number: NCT01258231

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.

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Key information

Conditions

Heart; Dysfunction Postoperative, Cardiac Surgery Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Disease Attributes Disease Susceptibility Genetic Predisposition to Disease Heart Diseases Heart Failure Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Undergoing heart surgery
  • Willing to provide consent

Exclusion criteria

  • Enrolled in a concurrent drug or device trial that precludes concurrent enrollment

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Johns Hopkins University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Texas Heart Institute
  • University of Texas Southwestern Medical Center

Registry information

Acronym: CABGGenomics

Important dates

Study start
2000
Primary completion
2030
Study completion
2030
First posted
Dec 10, 2010
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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