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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00883467

Acronym

IPC in MRI

Enrollment

Registered

2009-04-17

Start date

2008-05-31

Completion date

Unknown

Last updated

2009-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemia

Keywords

Ischemic Preconditioning, functional MRI, BOLD, Reperfusion

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.

Interventions

PROCEDUREpreconditioning

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

PROCEDUREno preconditioning

no preconditioning

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026