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

Medical College of Wisconsin

Status and phase: Enrolling; Phase 2

Conditions: Stroke

Treatments: Device: Ischemic Conditioning; Dietary Supplement: Antioxidant Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT06930638

PRO00054821

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 3 patient groups

Ischemic Conditioning - High

Experimental group

Description:

During each testing session, the investigators will be measuring how one treatment of ischemic conditioning affects blood flow and muscle function. One day participants will receive a high cuff inflation pressure on the leg, called ischemic conditioning - high (225 mmHg).

Treatment:

Device: Ischemic Conditioning

Ischemic Conditioning - Low

Experimental group

Description:

During each testing session, the investigators will be measuring how one treatment of ischemic conditioning affects blood flow and muscle function. One day participants will receive a low cuff inflation pressure on the leg, called ischemic conditioning - low (25 mmHg).

Treatment:

Device: Ischemic Conditioning

Antioxidant Supplement

Experimental group

Description:

During each testing session, the investigators will be measuring how one treatment of an over-the-counter antioxidant supplement affects blood flow and muscle function. One day participants will orally ingest an over-the-counter antioxidant supplement called MitoQ.

Treatment:

Dietary Supplement: Antioxidant Supplement