The Effects of Post-Conditioning and Administration of Vitamin C on Intramuscular High Energy Phosphate Levels (IRI in MRI)
|ClinicalTrials.gov Identifier: NCT00534924|
Recruitment Status : Unknown
Verified September 2007 by Medical University of Vienna.
Recruitment status was: Recruiting
First Posted : September 26, 2007
Last Update Posted : September 26, 2007
Ischemic injury to muscular tissue is common in cardiovascular medicine. The most effective treatment to avoid ischemic damage is the rapid re-establishment of reperfusion. However, reperfusion itself can result in additional damage to ischemic tissue. This phenomenon is called ischemia - reperfusion (IR) injury and is caused by different pathologic mechanisms.
Therapies are required which can be administered after the onset of an ischemic event to protect the tissue against IR injury. Therefore, a promising strategy to reduce IR injury is post-conditioning.
Likewise, pharmacological therapies administered after the onset of reperfusion might prevent tissue injury. We have recently shown that high concentrations of exogenous vitamin C abrogate experimental IR injury of the forearm vasculature in patients with peripheral artery disease and in healthy subjects.
We hypothesize that the administration of mechanical post-conditioning or of high-dose vitamin C may protect skeletal muscle against IR injury. This shall be studied employing MR spectroscopy of the leg, which is an established model to assess muscle aerobic energy metabolism.
Three periods, three way cross over study in 10 volunteers. One screening visit, three one-day study days with two washout periods of >3 days in between are scheduled for each participant. The order of experimental days will be randomized. After the last treatment a final follow-up examination will be performed within one week.
|Condition or disease||Intervention/treatment||Phase|
|Ischemia Reperfusion Injury||Drug: Vit C Procedure: Postconditioning Other: no intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Post-Conditioning and Administration of Vitamin C on Intramuscular High Energy Phosphate Levels|
|Study Start Date :||August 2007|
Placebo Comparator: 1
No intervention after IR injury
|Other: no intervention|
|Drug: Vit C|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534924
|Contact: Martin Andreas, MDemail@example.com|
|Medical University of Vienna||Recruiting|
|Contact: Martin Andreas, MD 0043404002983 firstname.lastname@example.org|
|Principal Investigator:||Michael Wolzt, MD, Prof.||Head of research group|