Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT01030367
Status:
UNKNOWN
Last Update Posted:
2009-12-11
First Post:
2009-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study of Organic Nitrates on Endothelial Function in CAD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-12-10', 'studyFirstSubmitDate': '2009-12-10', 'studyFirstSubmitQcDate': '2009-12-10', 'lastUpdatePostDateStruct': {'date': '2009-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial function Number of endothelial progenitor cells Function of endothelial progenitor cells', 'timeFrame': 'Baseline and after 14d'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary artery disease'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '17255540', 'type': 'BACKGROUND', 'citation': 'Thum T, Fraccarollo D, Thum S, Schultheiss M, Daiber A, Wenzel P, Munzel T, Ertl G, Bauersachs J. Differential effects of organic nitrates on endothelial progenitor cells are determined by oxidative stress. Arterioscler Thromb Vasc Biol. 2007 Apr;27(4):748-54. doi: 10.1161/01.ATV.0000258787.18982.73. Epub 2007 Jan 25.'}]}, 'descriptionModule': {'briefSummary': 'Organic nitrates increase levels of circulating endothelial progenitor cells (Thum et al., Arterioscler Thromb Vasc Biol. 2007 Apr;27(4):748-54). Here, we want to test the effects of two different organic nitrates (PETN, ISDN) on number and function of endothelial progenitor cells and endothelial function.', 'detailedDescription': 'In this pilot study we test the effects of two different organic nitrates (PETN, ISDN) on number and function of endothelial progenitor cells and endothelial function. These parameters will be measured before and after 14d of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Coronary artery disease, 2- or 3-vessel disease\n\nExclusion Criteria:\n\n* Acute myocardial infarction, acute heart failure, cancer, acute infections'}, 'identificationModule': {'nctId': 'NCT01030367', 'acronym': 'ONEEF', 'briefTitle': 'Pilot Study of Organic Nitrates on Endothelial Function in CAD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Julius-Maximilians University'}, 'officialTitle': 'Pilot Study of Organic Nitrates on Endothelial Progenitor Cells and Endothelial Function in Patients With Coronary Artery Disease', 'orgStudyIdInfo': {'id': '0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'PETN', 'interventionNames': ['Drug: PETN, ISDN']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'ISDN', 'interventionNames': ['Drug: PETN, ISDN']}, {'type': 'NO_INTERVENTION', 'label': '3', 'interventionNames': ['Drug: PETN, ISDN']}], 'interventions': [{'name': 'PETN, ISDN', 'type': 'DRUG', 'description': 'Oral dosing of organic nitrates PETN 2x 80mg per day ISDN 2x40mg per day', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97080', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Julius-Maximilians University', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'Thomas Thum, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Würzburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Julius-Maximilians University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Julius-Maximilians University', 'oldOrganization': 'Julius-Maximilians University'}}}}