Heart Institute BioRepository (HIBR) for Pediatric Heart Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Legal guardian unauthorized to consent

Families who choose Palliative care during pregnancy

Trial population

The study population will include any fetus, child, or adult who is at risk for or diagnosed with pediatric heart disease (PHD) or cardiovascular disease (CVD). Eligible participants include all Heart Institute patients across surgical, cardiac catheterization, advanced imaging, inpatient, perinatal, and outpatient clinical encounters. In addition, any pregnant individual carrying a fetus with a suspected cardiac diagnosis will be included.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Biological sample collection for repository

Blood samples will be collected for preparation of plasma and serum, extraction of DNA and isolation of circulating cells. Future analysis includes genotype-phenotype relationships using blood-tissue pairs.

Time frame
Day 1

Secondary outcomes

1

Data collection for repository

Demographic information, outcomes, risk factor, and other clinical data

Time frame
Day 1

Other outcomes

Sponsors and contacts

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