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NCT Number: NCT06930638

MitoQ and Ischemic Conditioning To Assess Vascular Health Outcomes

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location status: Recruiting

Location contact

Matthew J Durand, Ph.D.

CONTACT

[email protected]

414-955-5619

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ischemic Conditioning

Device

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.

Antioxidant supplement

Dietary 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 outcomes

  1. Brachial Artery Flow-Mediated Dilation

    Time frame: 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.

  2. Microvascular Vasodilation

    Time frame: 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 outcomes

  1. Muscle Tissue Oxygenation

    Time frame: 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.

  2. Blood Draw

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alicen Whitaker-Hilbig, DPT, PhD

CONTACT

[email protected]

414-955-5713

Jennifer Nguyen

CONTACT

[email protected]

414-955-5713

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

MitoQ and Ischemic Conditioning To Assess Vascular Health Outcomes (MITO Study)

Acronym: MITO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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