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Heart Institute BioRepository (HIBR) for Pediatric Heart Disease

Heart Institute BioRepository (HIBR) for Pediatric Heart Disease

Recruiting
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Phase N/A

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Overview

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.

Description

The HIBR is a prospective and retrospective observational repository. Designed as a core facility for Heart Institute investigators, it will grow into an institutional and eventually national resource. Located in dedicated research space within the Heart Institute, HIBR acquires, processes, organizes, and stores tissue and blood samples for current and future studies. Whole blood is used for DNA isolation, and the repository can perform limited wet-bench functions, including plasma isolation and B-lymphocyte transformation to generate immortalized cell lines and preserve genomic material. Samples may be collected at multiple time points, including during surgery, outpatient clinic visits, the perinatal period, and cardiac catheterizations, to capture comprehensive biological data across clinical encounters.

Eligibility

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 details
    Cardiovascular Diseases (CVD)

NCT07478354

Children's Hospital Medical Center, Cincinnati

13 May 2026

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