The Effects of Post-Conditioning and Administration of Vitamin C on Intramuscular High Energy Phosphate Levels (IRI in MRI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00534924
First received: September 24, 2007
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

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.

Study hypothesis

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.

Design

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 Intervention
Ischemia Reperfusion Injury
Drug: Vit C
Procedure: Postconditioning
Other: no intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Post-Conditioning and Administration of Vitamin C on Intramuscular High Energy Phosphate Levels

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Study Start Date: August 2007
Arms Assigned Interventions
Placebo Comparator: 1
No intervention after IR injury
Other: no intervention
Experimental: 2
Postconditioning
Procedure: Postconditioning
Experimental: 3
Vit. C
Drug: Vit C

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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:

Any of the following will exclude a subject from the study:

  • 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
  • History or presence of gastrointestinal, liver of kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of the study drug
  • Blood donation during the previous 3 weeks
  • History of hypersensitivity to parenteral vitamin C.
  • Glucose-6-phosphate dehydrogenase deficiency
  • Thalassemia, haemochromatosis
  • History of urolithiasis
  • Any metallic or paramagnetic device not removable
  • Claustrophobia
  • Regular use of supplementary oral Vitamin C or Vitamin C containing substances
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534924

Contacts
Contact: Martin Andreas, MD 0043404002983 martin.andreas@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria
Contact: Martin Andreas, MD    0043404002983    martin.andreas@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Michael Wolzt, MD, Prof. Head of research group
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00534924     History of Changes
Other Study ID Numbers: EudraCT: 2007-002520-16
Study First Received: September 24, 2007
Last Updated: September 24, 2007
Health Authority: Austria: AGES

Keywords provided by Medical University of Vienna:
IR injury
MRI
Vitamin C
Postconditioning

Additional relevant MeSH terms:
Reperfusion Injury
Cardiovascular Diseases
Pathologic Processes
Postoperative Complications
Vascular Diseases
Vitamins
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014