NCT06747806

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
30mo left

Started Dec 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Dec 2023Dec 2028

Study Start

First participant enrolled

December 18, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 24, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

5 years

First QC Date

November 22, 2024

Last Update Submit

December 12, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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

Study Arms (1)

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.

Procedure: Cardiac Surgery and Procedures

Interventions

To assess blood and tissue biomarkers of patients undergoing cardiac surgery

Patients who undergo cardiac surgery and procedures

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who undergo cardiac surgery at Advocate Children's Hospital (ACH)\& University of Chicago Medical Center (UCMC)

You may qualify if:

  • 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.

You may not qualify if:

  • Vulnerable Subjects/Subject Capacity to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Hyde Park, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Cardiac Surgical Procedures

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Valluvan Jeevanandam, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valluvan Jeevanandam, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2024

First Posted

December 24, 2024

Study Start

December 18, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations