Remote Ischemic Limb Preconditioning In Healthy Volunteers
Primary Purpose
Cerebrovascular Disease, Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
4x 5min Limb Preconditioning
3x 10min Limb Preconditioning
3x 10min Sham Preconditioning
Sponsored by
About this trial
This is an interventional other trial for Cerebrovascular Disease
Eligibility Criteria
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
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
4x 5min Limb Preconditioning
3x 10min Limb Preconditioning
3x 10min Sham Preconditioning
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Change in Vasomotor Reactivity to Carbon Dioxide (CO2)
Change in vasomotor reactivity to carbon dioxide (CO2) or breath holding from baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT02553655
First Posted
September 16, 2015
Last Updated
September 2, 2021
Sponsor
University of Miami
1. Study Identification
Unique Protocol Identification Number
NCT02553655
Brief Title
Remote Ischemic Limb Preconditioning In Healthy Volunteers
Official Title
Does Remote Ischemic Limb Preconditioning Improve Cerebral Vasomotor Reactivity in Healthy Volunteers?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disease, Stroke
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
4x 5min Limb Preconditioning
Arm Type
Active Comparator
Arm Description
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.
Arm Title
3x 10min Limb Preconditioning
Arm Type
Active Comparator
Arm Description
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.
Arm Title
3x 10min Sham Preconditioning
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
4x 5min Limb Preconditioning
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
3x 10min Limb Preconditioning
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
3x 10min Sham Preconditioning
Intervention Description
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 Outcome Measure Information:
Title
Change in Vasomotor Reactivity to Carbon Dioxide (CO2)
Description
Change in vasomotor reactivity to carbon dioxide (CO2) or breath holding from baseline
Time Frame
Baseline to 24 hours, Baseline to 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Koch, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Remote Ischemic Limb Preconditioning In Healthy Volunteers
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