NCT02553655

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2021

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

5.7 years

First QC Date

September 16, 2015

Last Update Submit

September 2, 2021

Conditions

Cerebrovascular DiseaseStroke

Outcome Measures

Primary Outcomes (1)

  • Change in Vasomotor Reactivity to Carbon Dioxide (CO2)

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

    Baseline to 24 hours, Baseline to 48 hours

Study Arms (3)

4x 5min Limb Preconditioning

ACTIVE COMPARATOR

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

3x 10min Limb Preconditioning

ACTIVE COMPARATOR

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

3x 10min Sham Preconditioning

SHAM COMPARATOR

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

4x 5min Limb PreconditioningPROCEDURE

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.

4x 5min Limb Preconditioning
3x 10min Limb PreconditioningPROCEDURE

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 Limb Preconditioning
3x 10min Sham PreconditioningPROCEDURE

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.

3x 10min Sham Preconditioning

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Cerebrovascular DisordersStroke

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sebastian Koch, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Neurology

Study Record Dates

First Submitted

September 16, 2015

First Posted

September 17, 2015

Study Start

October 1, 2015

Primary Completion

June 1, 2021

Study Completion

June 3, 2021

Last Updated

September 13, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)