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 : February 8, 2023
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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|
|Study Type :||Observational|
|Estimated Enrollment :||4000 participants|
|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|
Adult patients undergoing cardiac surgery
- 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.
- 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
Biospecimen Retention: Samples With DNA
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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|
- Undergoing heart surgery
- Willing to provide consent
- Enrolled in a concurrent drug or device trial that precludes concurrent enrollment
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
|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 firstname.lastname@example.org|
|Principal Investigator: Amanda A Fox, MD|
|Department Texas Heart Institute at St. Luke's Episcopal Hospital||Completed|
|Houston, Texas, United States, 77225|
|Principal Investigator:||Jochen D Muehlschlegel, MD MMSc, MPH||Brigham and Women's Hospital|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Jochen Daniel Muehlschlegel, MD, Associate Professor, Brigham and Women's Hospital|
|Other Study ID Numbers:||
5R01HL098601 ( U.S. NIH Grant/Contract )
|First Posted:||December 10, 2010 Key Record Dates|
|Last Update Posted:||February 8, 2023|
|Last Verified:||February 2023|
Genetic Predisposition to Disease