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

April 16, 2009 updated by: Medical University of Vienna

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna, Department of Clinical Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in cellular high energy phosphate levels and venous pH concentration for 31P MRS
Time Frame: during and 30 min after ischemia
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
during and 30 minutes after ischemia
Serum markers of myocellular injury (myoglobin, creatine-kinase)
Time Frame: prior to, directly and 24 hours after ischemia
prior to, directly and 24 hours after ischemia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Michael Wolzt, MD, MUV, Department of Clinical Pharmacology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

June 1, 2009

Study Registration Dates

First Submitted

April 16, 2009

First Submitted That Met QC Criteria

April 16, 2009

First Posted (Estimate)

April 17, 2009

Study Record Updates

Last Update Posted (Estimate)

April 17, 2009

Last Update Submitted That Met QC Criteria

April 16, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPC in MRI 040908

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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