Heart Institute Biobank & Registry for Adult Congenital Heart Disease and Related Disorders
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
- Successful establishment of biospecimen repository
研究概览
简要总结
A repository of biospecimens and detailed phenotypic information collected longitudinally from adults with congenital heart disease and related conditions, with an aim to facilitate future research on biologic mechanisms of underlying disease, compensation and deterioration; biologic correlates of patient experience and functional status; associations between clinical characteristics and various biomarkers; and predictors of clinical outcomes.
详细描述
The goals of this protocol are to collect, maintain, and manage tissue specimens of various types for adults with congenital heart disease, adults with related disorders, and a set of control participants. Ultimately, we plan to approach all clinical encounters for adults (≥16 years-old) in the Heart Institute (HI) - and, in the future with additional review, the cardiology departments of additional participating sites.
We will collect extensive data on all enrolled participants, and also collect information directly from participants (e.g., via surveys about symptoms and lifestyle, patient-reported outcome metrics) at baseline and on an ongoing basis (e.g. sequential outpatient visits and procedure encounters).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any person ≥ 16 years-old suspected of having or diagnosed with congenital heart disease (CHD), other cardiovascular disease (CVD), pulmonary hypertension, connective tissue disease, or genetic syndrome/diagnosis.
- •Additionally, a cohort (Control group A) of control subjects will be enrolled, again ≥16 years-old, self-reported non-smokers without a known history of diabetes mellitus, myocardial infarction, stroke, heart failure, or chronic kidney disease. These controls will be either:
- •A family member or other person accompanying a patient to a clinical encounter; or,
- •A volunteer recruited via an advertisement; or,
- •Another person who volunteers to enroll in HIBR-ACHD.
- •A cohort (Control group B) of comparison subjects who do not have CHD, but have a diagnosis of heart failure or pulmonary hypertension.
排除标准
- •Unable to provide informed consent/assent personally or via a legal guardian.
- •Considered unsafe to collect the biospecimen determined by either a clinical provider or an HIBR-ACHD investigator.
- •Overnight hospitalization for non-obstetric reason with discharge in the prior 30 days.
研究组 & 干预措施
No treatment
结局指标
主要结局
Successful establishment of biospecimen repository
时间窗: Day 1
Defined as the number and type of biospecimens collected and successfully linked with corresponding clinical and phenotypic data.
次要结局
- Longitudinal biospecimen availability(Day 1)