Recruiting

Observational Study

Sponsor:

University of Chicago

Code:

NCT06747806

Conditions

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Cardiac Surgery and Procedures

Study Details

Brief 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. 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

Study ID

NCT06747806

Start date

Dec 18, 2023

Status verified date

Dec, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Cardiac Surgery and Procedures

To assess blood and tissue biomarkers of patients undergoing cardiac surgery

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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Valluvan Jeevanandam, MD

7738345087jeevan@bsd.uchicago.edu

Leila Yazdanbakhsh

7738345087leila.yazdanbakhsh@bsd.uchicago.edu

Locations

The University of Chicago

Recruiting

Hyde Park, Illinois, United States, 60637

Contacts

Leila Yazdanbakhsh

7738345087leila.yazdanbakhsh@bsd.uchicago.edu

Principal Investigator:

Valluvan Jeevanandam

More Information

Sponsor

University of Chicago

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-12-19.