Recruiting

BioRepository

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT07478354

Conditions

Cardiovascular Diseases (CVD)

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this protocol is to redefine the Heart Institute BioRepository (HIBR) to facilitate Investigator-initiated and programmatic basic, translational, clinical and outcomes research. For the purposes of this protocol, "tissue" will refer to any gross specimen obtained from a patient, including but not limited to blood, cardiovascular tissue, urine, saliva, and other tissues and bodily fluids, including explanted non-human prosthetics or grafts. In this context, "tissue" is synonymous with "sample" or "specimen." A "BioRepository" functions to systematically collect, maintain and govern tissue specimens.

Conditions

Cardiovascular Diseases (CVD)

Study ID

NCT07478354

Start date

Jan 27, 2012

Status verified date

Apr, 2026

Completion date

Jan 1, 2050

Anticipated

Primary completion date

Jan 1, 2050

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Any fetus, child or adult at risk of or diagnosed with Pediatric Heart Disease (PHD) or Cardiovascular Disease (CVD)
  • Any HI patient, including the following types of encounters: Surgery or Cardiac Catheterization or Advanced Imaging encounters, Inpatient, including Cardiology service, consultation patients and Fetal Delivery, and Outpatient, including all HI-associated clinics and consultation services
  • Any female carrying a fetus with a suspected cardiac diagnosis

Exclusion Criteria

  • Legal guardian unauthorized to consent
  • Families who choose Palliative care during pregnancy

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Biological sample collection for repository [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Jeffrey Alten, MD

513-636-2871HIBioRepository@cchmc.org

Lindsay Fist

HIBioRepository@cchmc.org

Locations

Children's Hospital Medical Center, Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Jeffrey Alten, MD

513-636-2871HIBioRepository@cchmc.org

Lindsay Fist

HIBioRepository@cchmc.org

Principal Investigator:

Jeffrey Alten

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Apr 8, 2026

Last verified

Apr, 2026

Keywords

  • cardiovascular disease
  • Pediatric Heart disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-04-08.