MitoQ and Ischemic Conditioning To Assess Vascular Health Outcomes

Early Phase 1

Not yet recruiting

• Conditions: Stroke

• Registration Number: NCT06930638
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16
• Study Start: 2025-06-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Brachial Artery Flow-Mediated Dilation	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	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).

Secondary Outcome Measures

Name	Time	Method
Muscle Tissue Oxygenation	Change from BL to Post Intervention (5 hours)	We will also place a near-infrared spectroscopy (NIRS) pad on the thenar eminence of the non-paretic hand to non-invasively measure tissue oxygenation via infrared light following the pneumatic forearm cuff inflation/deflation.
Blood Draw	Change from BL to Post Intervention (5 hours)	We will collect blood before and after the intervention via an in-dwelling intravenous catheter. The blood draw analysis may include but will not be limited to examining complete blood counts, glucose levels, cholesterol, and plasma redox and bioenergetic analyses.