NCT00883467

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Last Updated

April 17, 2009

Status Verified

April 1, 2009

Enrollment Period

1.1 years

First QC Date

April 16, 2009

Last Update Submit

April 16, 2009

Conditions

Ischemia

Keywords

Ischemic Preconditioningfunctional MRIBOLDReperfusion

Outcome Measures

Primary Outcomes (3)

  • Change in cellular high energy phosphate levels and venous pH concentration for 31P MRS

    during and 30 min after ischemia

  • Main outcome variables: Change in cellular oxygen saturation for BOLD MRI

    during and 30 minutes after ischemia

  • Serum markers of myocellular injury (myoglobin, creatine-kinase)

    prior to, directly and 24 hours after ischemia

Study Arms (4)

1

OTHER

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

Procedure: no preconditioning

2

OTHER

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

3

OTHER

short time preconditioning, other details according arm 2

Procedure: preconditioning

4

OTHER

long time preconditioning, other details according arm 2

Procedure: preconditioning

Interventions

preconditioningPROCEDURE

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

34
no preconditioningPROCEDURE

no preconditioning

12

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, 1090, Austria

Location

Related Publications (1)

  • 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.

    PMID: 21718491DERIVED

MeSH Terms

Conditions

Ischemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Wolzt, MD

    MUV, Department of Clinical Pharmacology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 16, 2009

First Posted

April 17, 2009

Study Start

May 1, 2008

Primary Completion

June 1, 2009

Last Updated

April 17, 2009

Record last verified: 2009-04

Locations

AU(1)