JPRN-jRCTs042180027已完成2 期
Impact of Genetic Testing on Low-density Lipoprotein Cholesterol in Patients with Familial Hypercholesterolemia - GenTLe-FH study
omura Akihiro0 个研究点目标入组 53 人开始时间: 2019年1月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
研究概览
简要总结
We obtained written informed consent from 53 participants from April 2018. Then, we randomly allocated 50 patients to the intervention group (24 patients) or to the control (26 patients). The mean baseline LDL cholesterol levels were 132.7 mg/dL in the intervention group and 120.8 mg/dL in the control group. At week 24, mean changes of LDL-C from baseline were significantly larger in the intervention group than in control.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 15age old 至 ot applicable（—）
- 性别
- All
入选标准
- •We include the patients with all the following criteria:
- •1) Age equal or more than 15 years
- •2) Diagnosed with familial hypercholesterolemia per the criteria of the Japan
- •Atherosclerosis Society
- •3) Patients who have never got genetic tests, or have not yet returned genetic
- •results regarding familial hypercholesterolemia
- •4) Patients who can provide written informed consent
排除标准
- •We exclude patients with either of the following criteria:
- •1) Liver dysfunction (AST or ALT > 3 times the UNL)
- •2) Renal dysfunction (Cr equal or more than 2.0 mg/dL)
- •3) Immunosuppression
- •4) Active cancer
- •5) 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
- •6) Female with pregnancy or expected
- •7) Patients whose doctors in charge consider him/her inappropriate to participate
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