Heart Institute BioRepository (HIBR) for Pediatric Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Biological sample collection for repository
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Legal guardian unauthorized to consent
- •Families who choose Palliative care during pregnancy
结局指标
主要结局
Biological sample collection for repository
时间窗: Day 1
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.
次要结局
- Data collection for repository(Day 1)