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CompletedNCT02553655Updated Sep 13, 2021

Remote Ischemic Limb Preconditioning In Healthy Volunteers

An interventional study of 4x 5min Limb Preconditioning and 3x 10min Limb Preconditioning in Cerebrovascular Disease and Stroke, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-13.

Sponsored by University of Miami · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cerebrovascular Disease
  • Stroke
03

In context

Cerebrovascular Disorders

374 studies on the registry are indexed under Cerebrovascular Disorders; 129 are open to participants now.

This study's enrollment of 17 is below the median of 110 across 214 interventional studies indexed under Cerebrovascular Disorders.

Browse Cerebrovascular Disorders studies →

Lead sponsor

University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy volunteers

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
17 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • Procedure4x 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.

  • Procedure3x 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.

  • Procedure3x 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.

06

What researchers measure

Primary outcomes

  1. Change in Vasomotor Reactivity to Carbon Dioxide (CO2)

    Change in vasomotor reactivity to carbon dioxide (CO2) or breath holding from baseline

    Time frame: Baseline to 24 hours, Baseline to 48 hours

07

Study locations

1 site
  • University of Miami
    Miami, Florida 33136, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02553655
Lead sponsor
University of Miami
Responsible party
Sebastian Koch (Professor of Clinical Neurology, University of Miami) — Principal investigator
First posted
Sep 17, 2015
Start date
Oct 2015
Primary completion
Jun 1, 2021
Completion
Jun 3, 2021
Last update
Sep 13, 2021

Study contacts

Sebastian Koch, MD
principal investigator · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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