Remote Ischemic Limb Preconditioning In Healthy Volunteers

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553655
• Other study ID #: 20150648
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: June 3, 2021

Study information

• Verified date: September 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 3, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Disease
• Cerebrovascular Disorders
• Stroke

Intervention

Procedure:
• 4x 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.
• 3x 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.
• 3x 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Vasomotor Reactivity to Carbon Dioxide (CO2)	Change in vasomotor reactivity to carbon dioxide (CO2) or breath holding from baseline	Baseline to 24 hours, Baseline to 48 hours