Chronic Remote Ischemic Conditioning in Vascular Cognitive Impairment: A Dose Escalation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- RBC deformability index
研究概览
简要总结
To evaluate the dose-response of relevant blood biomarkers to remote ischemic conditioning in patients with age-related cerebral white matter hyperintensities on MRI, in preparation for a subsequent larger efficacy trial.
详细描述
Objective
The objective of this early phase study is to evaluate the dose-response of relevant blood biomarkers to remote ischemic conditioning in preparation for a subsequent larger efficacy trial. In addition, we will evaluate the tolerability and adherence to the treatment protocol.
Aim: We aim to measure blood biomarkers in response to daily remote ischemic conditioning (RIC) using a dose escalation study design in 40 patients with age-related cerebral white matter hyperintensities on MRI.
Hypothesis
We hypothesize that there will be a significant change in the biomarker levels in a dose dependent fashion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
concealed allocations and blinded laboratory personnel.
入排标准
- 年龄范围
- 56 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥55 years
- •Head MRI in the past 6 months showing no more than moderate age related cerebral white matter changes (Fazekas score 0-2).
- •Able to walk without assistance & independently perform basic activities of daily living.
- •Able to understand this study and agree for a valid consent.
排除标准
- •Prior non-lacunar (cortical) stroke.
- •Unable to cooperate with the use of the conditioning device.
- •Confounding illness that might interfere with the interpretation of results (such as active malignancy or multiple sclerosis).
- •Contraindication to transient arm ischemia in either arm (such as symptomatic peripheral artery disease).
结局指标
主要结局
RBC deformability index
时间窗: 5 weeks total study duration
from baseline to 4 weeks of treatment and one week off treatment
次要结局
- inflammatory and anti-inflammatory Interleukins(5 weeks)
- tolerability(4 weeks)