Heart Institute BioRepository (HIBR) for Pediatric Heart Disease
HIBR
1 other identifier
observational
5,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 27, 2012
CompletedFirst Submitted
Initial submission to the registry
March 5, 2026
CompletedFirst Posted
Study publicly available on registry
March 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2050
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2050
April 8, 2026
April 1, 2026
38 years
March 5, 2026
April 2, 2026
Conditions
Keywords
Outcome Measures
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.
Day 1
Secondary Outcomes (1)
Data collection for repository
Day 1
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Legal guardian unauthorized to consent
- Families who choose Palliative care during pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Medical Center, Cincinnati
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Alten
Children's Hospital Medical Center, Cincinnati
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2026
First Posted
March 17, 2026
Study Start
January 27, 2012
Primary Completion (Estimated)
January 1, 2050
Study Completion (Estimated)
January 1, 2050
Last Updated
April 8, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Upon IRB approval until end of study.
- Access Criteria
- 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.
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.