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

Sponsor
Medical University of Vienna (Other)
Overall Status
Unknown status
CT.gov ID
NCT00883467
Collaborator
(none)
16
Enrollment
1
Location
4
Arms

Study Details

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 Phase
  • Procedure: preconditioning
  • Procedure: no preconditioning
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 1, 2008
Anticipated Primary Completion Date :
Jun 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Other: 1

baseline MR signal prior to, during and 30 minutes after an ischemic period of 20 minutes

Procedure: no preconditioning
no preconditioning
Other: 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
Other: 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
Other: 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 [during and 30 min after ischemia]

  2. Main outcome variables: Change in cellular oxygen saturation for BOLD MRI [during and 30 minutes after ischemia]

  3. Serum markers of myocellular injury (myoglobin, creatine-kinase) [prior to, directly and 24 hours after ischemia]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00883467
Other Study ID Numbers:
  • IPC in MRI 040908
First Posted:
Apr 17, 2009
Last Update Posted:
Apr 17, 2009
Last Verified:
Apr 1, 2009
Keywords provided by , ,
Ischemic Preconditioning
functional MRI
BOLD
Reperfusion
Additional relevant MeSH terms:
Ischemia

Study Results

No Results Posted as of Apr 17, 2009