Overview

This trial is active, not recruiting.

Condition ischemia
Treatments preconditioning, no preconditioning
Sponsor Medical University of Vienna
Start date May 2008
End date June 2009
Trial size 16 participants
Trial identifier NCT00883467, IPC in MRI 040908

Summary

Ischemia reperfusion injury may be reduced by ischemic preconditioning. This projects aims to show the effects of short and long time ischemic preconditioning (both sequences 3 x 5 minutes) during and after an ischemic period of 20 minutes in healthy subjects by functional MRI. Ischemia is produces by cuff inflation to a suprasystolic pressure on one tight. Signal is acquired from calf muscles.

A cross-over design of 4 to 8 study periods is used, 4 different study days with 2 different MR measurement methods (BOLD imaging and high energy phosphates) are planned.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Other)
baseline MR signal prior to, during and 30 minutes after an ischemic period of 20 minutes
no preconditioning
no preconditioning
(Other)
baseline MR signal prior to, during and 30 minutes after an ischemic period of 20 minutes with additional 5 minutes of cuff stenosis directly after cuff release
no preconditioning
no preconditioning
(Other)
short time preconditioning, other details according arm 2
preconditioning
3 times of five minutes ischemia, produced by cuff inflation to a suprasystolic pressure positioned on the thigh
(Other)
long time preconditioning, other details according arm 2
preconditioning
3 times of five minutes ischemia, produced by cuff inflation to a suprasystolic pressure positioned on the thigh

Primary Outcomes

Measure
Change in cellular high energy phosphate levels and venous pH concentration for 31P MRS
time frame: during and 30 min after ischemia
Main outcome variables: Change in cellular oxygen saturation for BOLD MRI
time frame: during and 30 minutes after ischemia
Serum markers of myocellular injury (myoglobin, creatine-kinase)
time frame: prior to, directly and 24 hours after ischemia

Eligibility Criteria

Male participants from 18 years up to 45 years old.

Inclusion Criteria: - Men aged between 18 and 45 years - Nonsmoker for more than 3 months - Body mass index between 18 and 25 kg/m2 - Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Exclusion Criteria: - Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study - Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia - Treatment in the previous 3 weeks with any drug including over-the-counter drugs - Symptoms of a clinically relevant illness in the 2 weeks before the first study day - Blood donation during the previous 3 weeks - Any metallic, electric, electronic or magnetic device or object not removable - Claustrophobia

Additional Information

Official title The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia
Principal investigator Michael Wolzt, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2009.
Information provided to ClinicalTrials.gov by Medical University of Vienna.