Remote Ischemic Limb Preconditioning In Healthy Volunteers

NCT ID: NCT02553655

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2021-06-03

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.

Conditions

Cerebrovascular Disease; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

4x 5min Limb Preconditioning

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

3x 10min Limb Preconditioning

Intervention Type: PROCEDURE

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

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.

Group Type: SHAM_COMPARATOR

3x 10min Sham Preconditioning

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Sebastian Koch

Professor of Clinical Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sebastian Koch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20150648

Identifier Type: -

Identifier Source: org_study_id