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Identification of Genomic Predictors of Adverse Events After Cardiac Surgery

Identification of Genomic Predictors of Adverse Events After Cardiac Surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01258231
Acronym
CABGGenomics
Enrollment
4000
Registered
2010-12-10
Start date
2000-08-31
Completion date
2030-08-31
Last updated
2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Genetic Predisposition to Disease, Heart; Dysfunction Postoperative, Cardiac Surgery, Heart Failure, Myocardial Infarction

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).

Interventions

None listed

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Texas Heart Institute
CollaboratorOTHER
University of Texas Southwestern Medical Center
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER
Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Mortality (i.e. number of participants who are deceased during postoperative day 0 up to year 5)Day of procedure to year 5Data will be collected from electronic medical records; data points to be collected for this measurement include serum creatinine.

Other

MeasureTime frameDescription
Presence of Arrhythmia (i.e. number of patients who develop an arrhythmia after their cardiac surgery)Day of procedure to year 5Data 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)Day of procedure to year 5Data 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, IVDay of procedure to year 5This will be measured in accordance to New York Heart Association Guidelines.
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 7Data will be collected from electronic medical records; data points to be collected for this measurement include serum creatinine.
Quality of Life Survey - The Seattle Angina Questionnaire (SAQShortForm)Administered once prior to the procedure and 1 month to 5 years after hospital dischargeA questionnaire to assess for angina
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 dischargeA questionnaire to assess for overall health
Quality of Life Survey - The Kansas City Cardiomyopathy Questionnaire (KCCQShortForm)Administered once prior to the procedure and 1 month to 5 years after hospital dischargeA questionnaire to assess for heart failure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026