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Completed

NCT Number: NCT02553655

Remote Ischemic Limb Preconditioning In Healthy Volunteers

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers

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

Treatment and study plan

4x 5min Limb Preconditioning

Procedure

A blood pressure cuff is placed over the upper thigh of the participant(s) and inflated to 30 millimeters of mercury (mmHg) above systolic blood pressure. The loss of pedal pulses is confirmed by palpation. The cuff remains inflated for 5min and is followed by 5 minutes of reperfusion/rest. This will be repeated 4 times.

3x 10min Limb Preconditioning

Procedure

A blood pressure cuff is placed over the upper thigh of the participant(s) and inflated to 30 mmHg above systolic blood pressure. The loss of pedal pulses is confirmed by palpation. The cuff remains inflated for 10min and is followed by 5 minutes of reperfusion/rest. This will be repeated 3 times.

3x 10min Sham Preconditioning

Procedure

A blood pressure cuff is placed over the upper thigh of the participant(s) and inflated to 40 mmHg, sufficient to apply pressure but not affect blood flow. The presence of pedal pulses is confirmed by palpation. The cuff remains inflated for 10min and is followed by 5 minutes of rest. This will be repeated 3 times.

Primary outcomes

  1. Change in Vasomotor Reactivity to Carbon Dioxide (CO2)

    Time frame: Baseline to 24 hours, Baseline to 48 hours

    Change in vasomotor reactivity to carbon dioxide (CO2) or breath holding from baseline

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Does Remote Ischemic Limb Preconditioning Improve Cerebral Vasomotor Reactivity in Healthy Volunteers?

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Sep 17, 2015
Registry last updated
Sep 13, 2021

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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