Identification of Genomic Predictors of Adverse Events After Cardiac Surgery (CABGGenomics)

February 6, 2023 updated by: Jochen Daniel Muehlschlegel, MD, Brigham and Women's Hospital

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Completed
        • Brigham and Women's Hospital
    • Texas
      • Dallas, Texas, United States, 75390-9068
        • Recruiting
        • UT Southwestern Medical Center
      • Houston, Texas, United States, 77225
        • Completed
        • Department Texas Heart Institute at St. Luke's Episcopal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing heart surgery

Description

Inclusion Criteria:

  • Undergoing heart surgery
  • Willing to provide consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cardiac surgery
Adult patients undergoing cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day of procedure to year 5

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day of procedure to post procedure day 7
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.
Day of procedure to year 5
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.
Day of procedure to year 5
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.
Day of procedure to year 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
Administered once prior to the procedure and 1 month to 5 years after hospital discharge
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
Administered once prior to the procedure and 1 month to 5 years after hospital discharge
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
Administered once prior to the procedure and 1 month to 5 years after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2000

Primary Completion (ANTICIPATED)

August 1, 2030

Study Completion (ANTICIPATED)

August 1, 2030

Study Registration Dates

First Submitted

December 9, 2010

First Submitted That Met QC Criteria

December 9, 2010

First Posted (ESTIMATE)

December 10, 2010

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000P001639
  • 5R01HL098601 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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