MitoQ and Ischemic Conditioning To Assess Vascular Health Outcomes (MITO Study)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Brachial Artery Flow-Mediated Dilation
研究概览
简要总结
Stroke survivors have compromised vascular function which may contribute to secondary stroke risk, cardiovascular disease, and may limit their exercise tolerance. Preliminary data shows a single bout of ischemic conditioning or oral ingestion of an over-the-counter antioxidant supplement called MitoQ may improve vascular function and muscle activity in individuals post-stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 85 years of age
- •Cortical or sub-cortical stroke ≥ 6 months ago with residual hemiparesis
- •Able to give informed consent and follow 2-step command.
- •English Speaking
排除标准
- •Unable to stand from chair without physical assistance from another person (able to use assistive device).
- •History of blood clots in the extremities or any condition in which compression of the thigh or transient ischemia is contraindicated (i.e., wounds in the leg).
- •Chronic lasting symptoms (> 6 months) of severe COVID-19 (i.e., hospitalization)
- •History of head trauma or concussion within the past 6 months
- •Comorbid neurological disorder
- •Peripheral vascular disease
- •Myocardial infarction or arrhythmia in the previous year
- •Resting SBP ≥180 mmHg or DBP ≥ 100 mmHg
- •Pregnant or breastfeeding.
- •Other significant medical condition likely to influence study or jeopardize safety as assessed by the Primary Investigator
结局指标
主要结局
Brachial Artery Flow-Mediated Dilation
时间窗: Change from BL to Post Intervention (5 hours)
We will measure brachial artery vascular health in the non-paretic arm. Baseline brachial artery diameter and blood flow velocity through the artery will be measured before and after a pneumatic forearm cuff is inflated to 225 mmHg for five minutes.
Microvascular Vasodilation
时间窗: Change from BL to Post Intervention (5 hours)
Laser Doppler Flowmetry (LDF) with Dermal Microdialysis (DM) will measure blood flow flux during microinfusions of study drugs (limited to an area on the skin approximately the size of a nickel) to examine endothelial dependent vasodilation (Acetylcholine, ACh) and nitric-oxide mediated vasodilation (ACH +/- LNAME, and endothelial nitric oxide synthase inhibitor).
次要结局
- Muscle Tissue Oxygenation(Change from BL to Post Intervention (5 hours))
- Blood Draw(Change from BL to Post Intervention (5 hours))
研究者
Matthew J. Durand
Associate Professor
Medical College of Wisconsin