NCT03253432已完成不适用
INTegrating Active Case-finding With Next-generation Sequencing for Diagnosis Through Electronic Medical Records (IN-TANDEM): Familial Hypercholesterolemia Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 378
- 试验地点
- 2
- 主要终点
- Likelihood of having FH-causing mutation
研究概览
简要总结
The purpose of this study is to validate the use of the FH Foundation FIND FH® Algorithm as a clinical decision support tool. FIND FH (Flag/Identify/Network/Engage) is a national initiative that utilizes machine learning and data mining techniques to identify individuals whose profiles are consistent with FH patients. The algorithm will be tested in adults with at least one cardiovascular comorbidity. Study subjects will be asked to provide either a saliva, buccal or venous blood sample for DNA and biomarker analysis
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •At least one cardiovascular co-morbidity or receiving treatment for a cardiovascular comorbidity
- •Algorithm score 0-1
- •Most recent encounter with a provider within five years of query date
排除标准
- •Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, or confound study data
结局指标
主要结局
Likelihood of having FH-causing mutation
时间窗: 12 months
Proportion of subjects with causative mutation in higher algorithm score groups
次要结局
未报告次要终点
研究者
研究点 (2)
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