Cardiovascular DiseasesNCT06747806
Biobank Cardiac Surgery
An observational study of Cardiovascular Diseases, run by University of Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Cardiac Surgery and Procedures
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2023to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who undergo cardiac surgery at Advocate Children's Hospital (ACH)\& University of Chicago Medical Center (UCMC)
Who may be able to join
- 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.
Who cannot join
- Vulnerable Subjects/Subject Capacity to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Chicago
Hyde Park, Illinois, 60637
Valluvan Jeevanandam, MD
Leila Yazdanbakhsh, 7738345087, leila.yazdanbakhsh@bsd.uchicago.edu
About this study
Official title: 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Cardiac Surgery and Procedures
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Surgery and ProceduresProcedure or surgery
To assess blood and tissue biomarkers of patients undergoing cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Cardiac Surgery and Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of the elucidation in disease etiology from evaluating blood and tissue results
To acquire elucidation in disease etiology health by evaluating blood and tissue results of those with cardiac disease undergoing cardiac surgery.
Measured: 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
To acquire elucidation in disease translational health by evaluating blood and tissue results of those with cardiac disease undergoing cardiac surgery.
Measured: 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
To acquire elucidation in advancing public health by evaluating blood and tissue results of those with cardiac disease undergoing cardiac surgery.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start18 Dec 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valluvan Jeevanandam, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747806
- Sponsor's protocol ID
- IRB20-1974
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2024
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobank of Blood and Tissue Samples From Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06747806
- Acronym / sponsor ID
- IRB20-1974
- Conditions
- Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who undergo cardiac surgery and procedures | – | Procedure: Cardiac Surgery and ProceduresPatients who undergo cardiac surgery and procedures will have tissue specimens that are removed during surgery and collected blood samples of 5 mL. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who undergo cardiac surgery at Advocate Children's Hospital (ACH)\& University of Chicago Medical Center (UCMC)
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Vulnerable Subjects/Subject Capacity to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Surgery and ProceduresTo assess blood and tissue biomarkers of patients undergoing cardiac surgery | Procedure or surgery | Patients who undergo cardiac surgery and procedures |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valluvan Jeevanandam, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valluvan Jeevanandam, MD (7738345087, jeevan@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.