Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT00883467
Status:
UNKNOWN
Last Update Posted:
2009-04-17
First Post:
2009-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'lastUpdateSubmitDate': '2009-04-16', 'studyFirstSubmitDate': '2009-04-16', 'studyFirstSubmitQcDate': '2009-04-16', 'lastUpdatePostDateStruct': {'date': '2009-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cellular high energy phosphate levels and venous pH concentration for 31P MRS', 'timeFrame': 'during and 30 min after ischemia'}, {'measure': 'Main outcome variables: Change in cellular oxygen saturation for BOLD MRI', 'timeFrame': 'during and 30 minutes after ischemia'}, {'measure': 'Serum markers of myocellular injury (myoglobin, creatine-kinase)', 'timeFrame': 'prior to, directly and 24 hours after ischemia'}]}, 'conditionsModule': {'keywords': ['Ischemic Preconditioning', 'functional MRI', 'BOLD', 'Reperfusion'], 'conditions': ['Ischemia']}, 'referencesModule': {'references': [{'pmid': '21718491', 'type': 'DERIVED', 'citation': 'Andreas M, Schmid AI, Keilani M, Doberer D, Bartko J, Crevenna R, Moser E, Wolzt M. Effect of ischemic preconditioning in skeletal muscle measured by functional magnetic resonance imaging and spectroscopy: a randomized crossover trial. J Cardiovasc Magn Reson. 2011 Jun 30;13(1):32. doi: 10.1186/1532-429X-13-32.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nA 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men aged between 18 and 45 years\n* Nonsmoker for more than 3 months\n* Body mass index between 18 and 25 kg/m2\n* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant\n\nExclusion Criteria:\n\n* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study\n* Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia\n* Treatment in the previous 3 weeks with any drug including over-the-counter drugs\n* Symptoms of a clinically relevant illness in the 2 weeks before the first study day\n* Blood donation during the previous 3 weeks\n* Any metallic, electric, electronic or magnetic device or object not removable\n* Claustrophobia'}, 'identificationModule': {'nctId': 'NCT00883467', 'acronym': 'IPC in MRI', 'briefTitle': 'The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'The Effects of Preconditioning on Intramuscular High-Energy Phosphate Levels During Ischemia', 'orgStudyIdInfo': {'id': 'IPC in MRI 040908'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'baseline MR signal prior to, during and 30 minutes after an ischemic period of 20 minutes', 'interventionNames': ['Procedure: no preconditioning']}, {'type': 'OTHER', 'label': '2', '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', 'interventionNames': ['Procedure: no preconditioning']}, {'type': 'OTHER', 'label': '3', 'description': 'short time preconditioning, other details according arm 2', 'interventionNames': ['Procedure: preconditioning']}, {'type': 'OTHER', 'label': '4', 'description': 'long time preconditioning, other details according arm 2', 'interventionNames': ['Procedure: preconditioning']}], 'interventions': [{'name': 'preconditioning', 'type': 'PROCEDURE', 'description': '3 times of five minutes ischemia, produced by cuff inflation to a suprasystolic pressure positioned on the thigh', 'armGroupLabels': ['3', '4']}, {'name': 'no preconditioning', 'type': 'PROCEDURE', 'description': 'no preconditioning', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna, Department of Clinical Pharmacology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Michael Wolzt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MUV, Department of Clinical Pharmacology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. Dr. Michael Wolzt', 'oldOrganization': 'Medical University of Vienna, Department of Clinical Pharmacology'}}}}