NCT00791206

Brief Summary

Previously, the preconditioning signaling pathways have been studied on molecular level or in animal model. By using MR spectroscopy and imaging in a dynamic human model of preconditioning, we will have a better understanding how mitochondrial and endothelial function are affected by preconditioning in-vivo.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_2

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 16, 2013

Status Verified

December 1, 2013

Enrollment Period

4.6 years

First QC Date

November 13, 2008

Last Update Submit

December 13, 2013

Conditions

Ischemia

Keywords

exerciseischemiaMRIMRI spectroscopyIschemia preconditioning

Outcome Measures

Primary Outcomes (2)

  • Improvement in mitochondrial function following the preconditioning as evidenced by a faster rate of recovery of phosphocreatinine after exercise.

    2 hours

  • Improvement of endothelial and microvascular dysfunction induced by 20 minutes of forearm ischemia.

    1 hour

Study Arms (2)

1

EXPERIMENTAL
Procedure: Real preconditioning

2

OTHER
Procedure: Sham preconditioning

Interventions

Real preconditioningPROCEDURE

Preconditioning will consist of four 5 minutes cycles of upper limb ischemia interspaced with 5 minutes of reperfusion, using a blood-pressure cuff inflated to a pressure 15 mmHg greater than systolic arterial pressure.

1
Sham preconditioningPROCEDURE

Preconditioning will consist of four 5 minutes cycles of upper limb ischemia interspaced with 5 minutes of reperfusion, using a blood-pressure cuff inflated to a pressure 10mmHg with the same cycling protocol as the real preconditioning.

2

Eligibility Criteria

Age16 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy male and female volunteers
  • Post-pubescent non-athletes between the ages of \>16 and \<40 years of age.

You may not qualify if:

  • Older than 40 year old.
  • Younger than 16 year old.
  • Major medical condition
  • Illness, surgery or medical intervention in the last 48 hours.
  • Diabetes Mellitus
  • Caffeine intake in the last 48 hours
  • Athlete (more than 5 training sessions per week)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

IschemiaMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Andrew Redington, MD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Heart Centre-Cardiology Division

Study Record Dates

First Submitted

November 13, 2008

First Posted

November 14, 2008

Study Start

November 1, 2008

Primary Completion

June 1, 2013

Study Completion

June 1, 2014

Last Updated

December 16, 2013

Record last verified: 2013-12