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

Ischemia Clinical Trial

— IPC in MRI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00883467
• Other study ID #: IPC in MRI 040908
• Status: Active, not recruiting
• Phase: N/A
• First received: April 16, 2009
• Last updated: April 16, 2009
• Start date: May 2008

Study information

• Verified date: April 2009
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Ischemia

Intervention

Procedure:
• preconditioning
3 times of five minutes ischemia, produced by cuff inflation to a suprasystolic pressure positioned on the thigh
• no preconditioning
no preconditioning

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cellular high energy phosphate levels and venous pH concentration for 31P MRS		during and 30 min after ischemia	No
Primary	Main outcome variables: Change in cellular oxygen saturation for BOLD MRI		during and 30 minutes after ischemia	No
Primary	Serum markers of myocellular injury (myoglobin, creatine-kinase)		prior to, directly and 24 hours after ischemia	Yes