NCT04036799进行中（未招募）不适用
Development of a Risk Calculator to Predict Sudden Cardiac Death in Children With Hypertrophic Cardiomyopathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 572
- 主要终点
- Number of Participants With a Composite Sudden Cardiac Death Event
研究概览
简要总结
This is a retrospective cohort study of pediatric hypertrophic cardiomyopathy (HCM) patients using chart and registry review methodology. The studies objective is to develop and validate a sudden cardiac death (SCD) risk calculator that is age-appropriate for children with HCM that includes clinical and genetic factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •phenotype-positive patients diagnosed with hypertrophic cardiomyopathy
- •phenotype-negative, genotype positive patients considered at risk for developing hypertrophic cardiomyopathy
排除标准
- •Neuromuscular, metabolic, syndromic (other than Noonan Syndrome and related RAS-opathies) or endocrine (including infants of diabetic mothers) causes of HCM
- •(Other treatable causes of left ventricular hypertrophy (systemic hypertension, anatomic defects causing left ventricular outflow tract obstruction e.g. aortic stenosis, subAS, subaortic membrane, coarctation)
结局指标
主要结局
Number of Participants With a Composite Sudden Cardiac Death Event
时间窗: Time to a composite sudden cardiac death event during 5-year follow-up
The composite SCD event includes post diagnosis SCD, aborted SCD (including ventricular fibrillation, sustained ventricular tachycardia), primary ICD insertion with appropriate shock, secondary ICD insertion
次要结局
未报告次要终点
研究者
Seema Mital
Principal Investigator
The Hospital for Sick Children
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