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The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia (IPC in MRI)

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ClinicalTrials.gov Identifier: NCT00883467
Recruitment Status : Unknown
Verified April 2009 by Medical University of Vienna.
Recruitment status was:  Active, not recruiting
First Posted : April 17, 2009
Last Update Posted : April 17, 2009
Sponsor:
Information provided by:

Study Description
Brief 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.


Condition or disease Intervention/treatment
Ischemia Procedure: preconditioning Procedure: no preconditioning

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia
Study Start Date : May 2008
Estimated Primary Completion Date : June 2009
Arms and Interventions

Arm Intervention/treatment
1
baseline MR signal prior to, during and 30 minutes after an ischemic period of 20 minutes
Procedure: no preconditioning
no preconditioning
2
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
Procedure: no preconditioning
no preconditioning
3
short time preconditioning, other details according arm 2
Procedure: preconditioning
3 times of five minutes ischemia, produced by cuff inflation to a suprasystolic pressure positioned on the thigh
4
long time preconditioning, other details according arm 2
Procedure: preconditioning
3 times of five minutes ischemia, produced by cuff inflation to a suprasystolic pressure positioned on the thigh


Outcome Measures

Primary Outcome Measures :
  1. Change in cellular high energy phosphate levels and venous pH concentration for 31P MRS [ Time Frame: during and 30 min after ischemia ]
  2. Main outcome variables: Change in cellular oxygen saturation for BOLD MRI [ Time Frame: during and 30 minutes after ischemia ]
  3. Serum markers of myocellular injury (myoglobin, creatine-kinase) [ Time Frame: prior to, directly and 24 hours after ischemia ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883467


Locations
Austria
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Michael Wolzt, MD MUV, Department of Clinical Pharmacology
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. Michael Wolzt, Medical University of Vienna, Department of Clinical Pharmacology
ClinicalTrials.gov Identifier: NCT00883467     History of Changes
Other Study ID Numbers: IPC in MRI 040908
First Posted: April 17, 2009    Key Record Dates
Last Update Posted: April 17, 2009
Last Verified: April 2009

Keywords provided by Medical University of Vienna:
Ischemic Preconditioning
functional MRI
BOLD
Reperfusion

Additional relevant MeSH terms:
Ischemia
Pathologic Processes