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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
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebrovascular Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
September 16, 2015
Last Updated
September 2, 2021
Sponsor
University of Miami
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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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