Remote Ischemic Limb Preconditioning In Healthy Volunteers

Not Applicable

Completed

• Conditions: Stroke; Cerebrovascular Disease
• Interventions: Procedure: 3x 10min Limb Preconditioning; Procedure: 4x 5min Limb Preconditioning; Procedure: 3x 10min Sham Preconditioning

• Registration Number: NCT02553655
• Lead Sponsor: University of Miami

Brief Summary

The investigators would like to determine if remote ischemic leg preconditioning in healthy volunteers improves cerebral vasomotor reactivity as measured by breath holding and transcranial doppler vasomotor reactivity.

Detailed Description

This study is to determine if remote ischemic leg preconditioning improves short and long term cerebral vasomotor reactivity in healthy volunteers as measured by breath holding and transcranial doppler vasomotor reactivity. Previous studies on brachial vasomotor reactivity have shown a beneficial effect of remote ischemic preconditioning. It remains uncertain if a similar beneficial effect can be reproduced with cerebral vasomotor testing. Many biological mechanisms and effector pathways triggered by preconditioning have demonstrated endothelial protection and beneficial vascular effects.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-09-16
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-17
• Study Start: 2015-10
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-03
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-02
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Healthy volunteers

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Exclusion Criteria

• Presence of chronic medical conditions such as diabetes, hypertension, cardiac disease etc.
• Any prescribed medication
• Pregnancy [by history and last menstrual period]
• Any leg injury that would, in the opinion of the investigator, affect preconditioning

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3x 10min Limb Preconditioning	3x 10min Limb Preconditioning	Either the right or left leg of the participant(s) will be made transiently ischemic for 10 minutes following by 5 minutes of rest. This will be repeated for 3 times.
4x 5min Limb Preconditioning	4x 5min Limb Preconditioning	Either the right or left leg of the participant(s) will be made transiently ischemic for 5 minutes following by 5 minutes of rest. This will be repeated for 4 times.
3x 10min Sham Preconditioning	3x 10min Sham Preconditioning	Either the right or left leg of the participant(s) will be squeezed without causing ischemia for 10 minutes following by 5 minutes of rest. This will be repeated for 3 times.

Primary Outcome Measures

Name	Time	Method
Change in Vasomotor Reactivity to Carbon Dioxide (CO2)	Baseline to 24 hours, Baseline to 48 hours	Change in vasomotor reactivity to carbon dioxide (CO2) or breath holding from baseline

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States