Overview

This trial is active, not recruiting.

Condition ischemia
Treatments real preconditioning, sham preconditioning
Phase phase 2
Sponsor The Hospital for Sick Children
Start date November 2008
End date June 2013
Trial size 20 participants
Trial identifier NCT00791206, 1000012859

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking single blind (subject)
Arm
(Experimental)
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.
(Other)
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.

Primary Outcomes

Measure
Improvement in mitochondrial function following the preconditioning as evidenced by a faster rate of recovery of phosphocreatinine after exercise.
time frame: 2 hours
Improvement of endothelial and microvascular dysfunction induced by 20 minutes of forearm ischemia.
time frame: 1 hour

Eligibility Criteria

Male or female participants from 16 years up to 40 years old.

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)

Additional Information

Official title Single Blind Randomized Controlled Crossover Trial of the Effects of Remote Preconditioning on the Tissue Metabolism During Exercise and Ischemia
Principal investigator Andrew Redington, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by The Hospital for Sick Children.