The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia
This trial is active, not recruiting.
|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|
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.
|Intervention model||crossover assignment|
|Primary purpose||basic science|
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
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
|Official title||The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia|
|Principal investigator||Michael Wolzt, MD|
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