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

Primary Purpose

Ischemia

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
preconditioning
no preconditioning
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ischemia focused on measuring Ischemic Preconditioning, functional MRI, BOLD, Reperfusion

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Medical University of Vienna, Department of Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

1

2

3

4

Arm Description

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

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

short time preconditioning, other details according arm 2

long time preconditioning, other details according arm 2

Outcomes

Primary Outcome Measures

Change in cellular high energy phosphate levels and venous pH concentration for 31P MRS
Main outcome variables: Change in cellular oxygen saturation for BOLD MRI
Serum markers of myocellular injury (myoglobin, creatine-kinase)

Secondary Outcome Measures

Full Information

First Posted
April 16, 2009
Last Updated
April 16, 2009
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00883467
Brief Title
The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia
Acronym
IPC in MRI
Official Title
The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia
Keywords
Ischemic Preconditioning, functional MRI, BOLD, Reperfusion

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
baseline MR signal prior to, during and 30 minutes after an ischemic period of 20 minutes
Arm Title
2
Arm Type
Other
Arm Description
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
Arm Title
3
Arm Type
Other
Arm Description
short time preconditioning, other details according arm 2
Arm Title
4
Arm Type
Other
Arm Description
long time preconditioning, other details according arm 2
Intervention Type
Procedure
Intervention Name(s)
preconditioning
Intervention Description
3 times of five minutes ischemia, produced by cuff inflation to a suprasystolic pressure positioned on the thigh
Intervention Type
Procedure
Intervention Name(s)
no preconditioning
Intervention Description
no preconditioning
Primary Outcome Measure Information:
Title
Change in cellular high energy phosphate levels and venous pH concentration for 31P MRS
Time Frame
during and 30 min after ischemia
Title
Main outcome variables: Change in cellular oxygen saturation for BOLD MRI
Time Frame
during and 30 minutes after ischemia
Title
Serum markers of myocellular injury (myoglobin, creatine-kinase)
Time Frame
prior to, directly and 24 hours after ischemia

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Wolzt, MD
Organizational Affiliation
MUV, Department of Clinical Pharmacology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Department of Clinical Pharmacology
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
21718491
Citation
Andreas M, Schmid AI, Keilani M, Doberer D, Bartko J, Crevenna R, Moser E, Wolzt M. Effect of ischemic preconditioning in skeletal muscle measured by functional magnetic resonance imaging and spectroscopy: a randomized crossover trial. J Cardiovasc Magn Reson. 2011 Jun 30;13(1):32. doi: 10.1186/1532-429X-13-32.
Results Reference
derived

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The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia

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