jRCTs042180027已完成不适用
Impact of Genetic Testing on Low-density Lipoprotein Cholesterol in Patients with Familial Hypercholesterolemia (GenTLe-FH study)
未提供0 个研究点目标入组 100 人开始时间: 2018年4月3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
- 100
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 15age old over 至 No limit（—）
- 性别
- All
入选标准
- •We include the patients with all the following criteria:
- •Age equal or more than 15 years
- •Diagnosed with familial hypercholesterolemia per the criteria of the Japan
- •Atherosclerosis Society
- •Patients who have never got genetic tests, or have not yet returned genetic
- •results regarding familial hypercholesterolemia
- •Patients who can provide written informed consent
排除标准
- •We exclude patients with either of the following criteria:
- •Liver dysfunction (AST or ALT > 3 times the UNL)
- •Renal dysfunction (Cr equal or more than 2.0 mg/dL)
- •Immunosuppression
- •Active cancer
- •Previous history of coronary heart disease:
- •i) Myocardial infarction
- •ii) History of percutaneous coronary intervention or coronary artery bypass graft
- •iii) Coronary stenosis (equal or more than 75%) previously detected by coronary angiography
- •Female with pregnancy or expected
- •Patients whose doctors in charge consider him/her inappropriate to participate
结局指标
主要结局
-
The plasma LDL cholesterol levels at 24 weeks
次要结局
- Patients Satisfaction Questionnaire Short Form (PSQ-18) scores(24 and 48 weeks)
研究者
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