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

Medical University of Vienna

Status: Unknown

Conditions: Ischemia

Treatments: Procedure: no preconditioning; Procedure: preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT00883467

IPC in MRI 040908

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

16 participants in 4 patient groups

1

Other group

Description:

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

Treatment:

Procedure: no preconditioning

2

Other group

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

Treatment:

Procedure: no preconditioning

3

Other group

Description:

short time preconditioning, other details according arm 2

Treatment:

Procedure: preconditioning

4

Other group

Description:

long time preconditioning, other details according arm 2

Treatment:

Procedure: preconditioning