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

NCT ID: NCT00883467

Last Updated: 2009-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

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

Group Type OTHER

no preconditioning

Intervention Type PROCEDURE

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

Group Type OTHER

no preconditioning

Intervention Type PROCEDURE

no preconditioning

3

short time preconditioning, other details according arm 2

Group Type OTHER

preconditioning

Intervention Type PROCEDURE

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

Group Type OTHER

preconditioning

Intervention Type PROCEDURE

3 times of five minutes ischemia, produced by cuff inflation to a suprasystolic pressure positioned on the thigh

Interventions

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preconditioning

3 times of five minutes ischemia, produced by cuff inflation to a suprasystolic pressure positioned on the thigh

Intervention Type PROCEDURE

no preconditioning

no preconditioning

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Medical University of Vienna, Department of Clinical Pharmacology

Principal Investigators

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Michael Wolzt, MD

Role: PRINCIPAL_INVESTIGATOR

MUV, Department of Clinical Pharmacology

Locations

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Medical University of Vienna, Department of Clinical Pharmacology

Vienna, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 21718491 (View on PubMed)

Other Identifiers

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IPC in MRI 040908

Identifier Type: -

Identifier Source: org_study_id

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