Identification of Genomic Predictors of Adverse Events After Cardiac Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-90
SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Undergoing heart surgery

Willing to provide consent

Disqualifiers

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

Trial population

Adult patients undergoing heart surgery

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

4,000 Participants
are grouped into 1 trial group
Group A: Cardiac surgery

Trial outcomes

Primary outcomes

1

Mortality (i.e. number of participants who are deceased during postoperative day 0 up to year 5)

Data will be collected from electronic medical records; data points to be collected for this measurement include serum creatinine.

Time frame
Day of procedure to year 5

Secondary outcomes

Other outcomes

1

Acute Kidney Injury using KDIGO criteria: albumin/creatinine ratio (>/= 300 mg/g) and eGRF (< 60 mL/min/1.73^2)

Data will be collected from electronic medical records; data points to be collected for this measurement include serum creatinine.

Time frame
Day of procedure to post procedure day 7
2

Presence of Arrhythmia (i.e. number of patients who develop an arrhythmia after their cardiac surgery)

Data will be collected from electronic medical records; data points to be collected for this measurement include post-procedural EKG reports and progress notes.

Time frame
Day of procedure to year 5
3

Myocardial Infarction (i.e. number of participants who develop a MI during postoperative day 0 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.

Time frame
Day of procedure to year 5
4

Heart failure per NYHA class II, III, IV

This will be measured in accordance to New York Heart Association Guidelines.

Time frame
Day of procedure to year 5

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Johns Hopkins University

Sponsor institution

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Texas Heart Institute

Collaborator

University of Texas Southwestern Medical Center

Collaborator

Johns Hopkins University

Collaborator