MitoQ and Ischemic Conditioning To Assess Vascular Health Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ischemic Conditioning, Antioxidant Supplement.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
MitoQ and Ischemic Conditioning To Assess Vascular Health Outcomes (MITO Study)
Overview
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.
Interventions
- Device Ischemic Conditioning
The cuff will be placed around the proximal, non-affected thigh and inflated for 5 minutes in a supine or semi-reclined position, then released for a 5-minute recovery period. Five cycles of inflation and recovery will be performed (45 minutes total).These inflations will be done using a cuff similar to what is used for taking blood pressure. - Dietary supplement Antioxidant Supplement
MitoQ is an over the counter supplement that increases delivery to the mitochondria. Similar to studies performed in middle age/older adults and individuals with peripheral arterial disease, we will administer 1 single oral dose of 80mg of MitoQ or a placebo pill. As MitoQ reaches peak concentrations at \~40 to 60 minutes after ingestion, we will wait 45 minutes (time matched to Ischemic conditioning).
Primary outcome measures
- Brachial Artery Flow-Mediated Dilation [Time frame: Change from BL to Post Intervention (5 hours)]
- Microvascular Vasodilation [Time frame: Change from BL to Post Intervention (5 hours)]
Secondary outcome measures (2)
- Muscle Tissue Oxygenation [Time frame: Change from BL to Post Intervention (5 hours)]
- Blood Draw [Time frame: Change from BL to Post Intervention (5 hours)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT06930638 · PRO00054821