Trial of the Effects of Remote Preconditioning on the Tissue Metabolism During Exercise and Ischemia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Andrew Redington, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00791206
First received: November 13, 2008
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Ischemia
Procedure: Real preconditioning
Procedure: Sham preconditioning
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Single Blind Randomized Controlled Crossover Trial of the Effects of Remote Preconditioning on the Tissue Metabolism During Exercise and Ischemia

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Improvement in mitochondrial function following the preconditioning as evidenced by a faster rate of recovery of phosphocreatinine after exercise. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Improvement of endothelial and microvascular dysfunction induced by 20 minutes of forearm ischemia. [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2008
Estimated Study Completion Date: June 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Procedure: Real preconditioning
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.
2 Procedure: Sham preconditioning
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.

Detailed Description:

Ischemic preconditioning is a mechanism that protects tissue against ischemia-reperfusion injury. The protective effect of preconditioning is induced by short periods (1-5 minutes) of non-lethal ischemia to the target tissue, which becomes resistant to a prolonged, otherwise lethal, period of ischemia. Despite its proven potency in experimental models, ischemic preconditioning has not reached widespread clinical application because of the difficulties in applying the stimulus to the target organ (eg Heart, Brain), and even brief ischemia to the target organ can cause dysfunction.

Remote ischemic preconditioning (RIPC) is a more clinically relevant stimulus. It has been shown that preconditioning of one coronary territory induces ischemia protection in other parts of the heart. Subsequently, other studies have shown, in rodent models, that preconditioning of one organ (eg kidney) could induce protection in other organs (eg heart). We recently have confirmed, in a series of animal and human preclinical studies, that this concept can be widened; ultimately showing that four 5-minute episodes of ischemia to the skeletal limb muscles (induced by inflating a standard blood pressure cuff to a level higher than the blood pressure) protects the heart and lungs against ischemia-reperfusion injury in children undergoing cardiac surgery using cardiopulmonary bypass.

The current research is designed to investigate with MRI spectroscopy techonology, the potential physiological mechanisms involved in the protective effects of preconditioning, and the effects of ischemia and exercise.

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00791206

Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Andrew Redington, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Andrew Redington, Head, Heart Centre-Cardiology Division, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00791206     History of Changes
Other Study ID Numbers: 1000012859
Study First Received: November 13, 2008
Last Updated: December 13, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
exercise
ischemia
MRI
MRI spectroscopy
Ischemia preconditioning

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014