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Remote Ischemic Limb Preconditioning In Healthy Volunteers

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02553655
Enrollment
17
Registered
2015-09-17
Start date
2015-10-31
Completion date
2021-06-03
Last updated
2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Disease, Stroke

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.

Interventions

PROCEDURE4x 5min Limb Preconditioning

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.

PROCEDURE3x 10min Limb Preconditioning

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.

PROCEDURE3x 10min Sham Preconditioning

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.

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026