The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Flow-mediated vasodilatation/endothelium-dependent vasodilatation
研究概览
简要总结
There is an on-going discussion weather remote ischemic conditioning (RIC) is effective in limiting the damage of reperfusion injury in STEMI patients. The results from recent RCTs have been variable and most have not shown convincing positive results when analyzing hard endpoints. Hence, there is a great need to evaluate the impact of comorbidities on the effectiveness of RIC. Therefore, we have designed a study to evaluate the impact of hypercholesterolemia on the RIC response by evaluating ischemia-induced endothelial dysfunction.
Aim: To investigate the impact of hypercholesterolemia on the RIC response in counteracting ischemia-induced endothelial dysfunction.
详细描述
Study population:
We plan to include 12 poorly controlled/newly diagnosed subjects with familiar hypercholesterolemia (FH) and 12 age-matched control subjects.
Inclusion criteria (FH subjects)
- Poorly treated FH, defined as LDL-C >5.5 mmol/L.
- Age, >18 and <65 years of age.
Exclusion criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Poorly treated FH, defined as LDL-C >5.5 mmol/L.
- •Age, >18 and <65 years of age.
- •A age matched control-group.
排除标准
- •Additional cardiovascular comorbidities such as diabetes mellitus, coronary artery disease, or kidney failure.
- •Any condition which interfere with the outcome recording for example atrial fibrillation.
- •Unwillingness to participate.
- •Concurrently participating in another interventional trial.
研究组 & 干预措施
Ischemia reperfusion +remote ischemic conditioning
Active administration of short cykcles of ischemia.
干预措施: Remote ischemic conditioning (Procedure)
Ischemia reperfusion +sham
Placebo experiment without remote ischemic conditioning.
干预措施: Remote ischemic conditioning (Procedure)
结局指标
主要结局
Flow-mediated vasodilatation/endothelium-dependent vasodilatation
时间窗: 20 min post-reperfusion
A ultrasound based technic for evaluation of endothelial function
次要结局
未报告次要终点