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.

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.

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

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.

Identifiable information (Name/Medical Record Number), geo-coding, or a limited dataset can be provided to CCHMC investigators (Date of Birth/Death, Date of Procedure, Diagnosis, Age, etc.). Identifiable information will not be provided to outside organizations, only a limited data set or geo-coding may be provided if deemed necessary. This will only be provided once the investigator has IRB approval.

Upon IRB approval until end of study.

A limited Case Report Form will be constructed at the time of enrollment and maintained in the HIBR data warehouse (BTM). Personal identification items will include the name and medical record number. Comprehensive clinical or study information will be maintained in a separate secure database (HIDR) with appropriate quality control and audit trail (REDCap or comparable database).

At the time a sample is requested for research purposes, Investigators will be provided with the least amount of identifying information as possible to conduct the research study. Identifiable information (Name/Medical Record Number), geo-coding, or a limited dataset can be provided to CCHMC investigators (Date of Birth/Death, Date of Procedure, Diagnosis, Age, etc.). Identifiable information will not be provided to outside organizations, only a only a limited data set or geo-coding may be provided if deemed necessary.