- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06747806
Biobank Cardiac Surgery
Biobank of Blood and Tissue Samples From Patients Undergoing Cardiac Surgery
Treatment strategies for cardiac surgery patients have been evolving significantly for the last decade. While clinical outcomes have been improving, there are still significant areas unexplored in these patients. Cardiac surgery, or cardiovascular surgery, is surgery on the heart or great vessels performed by cardiac surgeons. It is often used to treat complications of ischemic heart disease (for example, with coronary artery bypass grafting); to correct congenital heart disease; or to treat valvular heart disease from various causes, including endocarditis, rheumatic heart disease, and atherosclerosis.
Biobanking is a fundamental process required in the better understanding of human diseases together with their underlying mechanisms. Biobanking refers to the process by which samples of bodily fluid or tissue are collected for research use to improve the understanding of health and disease. For this study, the investigator's objective is to acquire elucidation in disease etiology, translation, and advancing public health by evaluating blood and tissue results of those with cardiac disease undergoing cardiac surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Leila Yazdanbakhsh
- Phone Number: 7738345087
- Email: leila.yazdanbakhsh@bsd.uchicago.edu
Study Contact Backup
- Name: Valluvan Jeevanandam, MD
- Phone Number: 7738345087
- Email: jeevan@bsd.uchicago.edu
Study Locations
-
-
Illinois
-
Hyde Park, Illinois, United States, 60637
- Recruiting
- The University of Chicago
-
Contact:
- Leila Yazdanbakhsh
- Phone Number: 7738345087
- Email: leila.yazdanbakhsh@bsd.uchicago.edu
-
Contact:
- Valluvan Jeevanandam, MD
-
Principal Investigator:
- Valluvan Jeevanandam
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients who undergo cardiac surgery at Advocate Children's Hospital (ACH)& University of Chicago Medical Center (UCMC) by the ACH & UC Cardiothoracic Surgery Research team who are pediatric neonates and up.
- Patients will only be English speaking.
Exclusion Criteria:
- Vulnerable Subjects/Subject Capacity to provide consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients who undergo cardiac surgery and procedures
Patients who undergo cardiac surgery and procedures will have tissue specimens that are removed during surgery and collected blood samples of 5 mL.
|
To assess blood and tissue biomarkers of patients undergoing cardiac surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Concentration of the elucidation in disease etiology from evaluating blood and tissue results
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
|
To acquire elucidation in disease etiology health by evaluating blood and tissue results of those with cardiac disease undergoing cardiac surgery.
|
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
|
|
Concentration of the elucidation in disease translation from evaluating blood and tissue results
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
|
To acquire elucidation in disease translational health by evaluating blood and tissue results of those with cardiac disease undergoing cardiac surgery.
|
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
|
|
Concentration of the elucidation in advancing public health by evaluating blood and tissue results
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
|
To acquire elucidation in advancing public health by evaluating blood and tissue results of those with cardiac disease undergoing cardiac surgery.
|
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Valluvan Jeevanandam, MD, University of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB20-1974
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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