跳至主要内容
临床试验/NCT03253432
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

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 378 人开始时间: 2017年7月20日最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (2)

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