Remote Ischemic Limb Preconditioning In Healthy Volunteers
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 4x 5min Limb Preconditioning 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. |
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.
|
| Active Comparator: 3x 10min Limb Preconditioning 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. |
Procedure: 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.
|
| Sham Comparator: 3x 10min Sham Preconditioning 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. |
Procedure: 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.
|
Outcome Measures
Primary Outcome Measures
- Change in Vasomotor Reactivity to Carbon Dioxide (CO2) [Baseline to 24 hours, Baseline to 48 hours]
Change in vasomotor reactivity to carbon dioxide (CO2) or breath holding from baseline
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami | Miami | Florida | United States | 33136 |
Sponsors and Collaborators
- University of Miami
Investigators
- Principal Investigator: Sebastian Koch, MD, University of Miami
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20150648