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 volunteersQualifiers
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
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Data collection for repository
Demographic information, outcomes, risk factor, and other clinical data
Sponsors and contacts
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