The Effect of Remote Ischemic Conditioning in Patients With Hypercholesterolemia
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Hypercholesteremia
- 发起方
- Karolinska Institutet
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Flow-mediated vasodilatation/endothelium-dependent vasodilatation
- 状态
- 已完成
- 最后更新
- 4年前
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 * Additional cardiovascular comorbidities such as diabetes mellitus, coronary artery disease, or kidney failure. * Unwillingness to participate. * Concurrently participating in another interventional trial. Main exposure: Remote ischemic conditioning, i.e. 4 cycles of 5 minutes of ischemia to the lower limb. Comparision group: Cross over design, patients preform the protocol twice, once with sham and once with RIC. Also a group of healthy matched controls will be recruited. Outcome: Change in FMD after 20 minutes of ischemia and 20 minutes of reperfusion with the exposure of either sham or RIC. Design: Randomized interventional cross-over.
研究者
入排标准
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.
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