Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-27 @ 3:49 PM
Study NCT ID:
NCT00947050
Status:
COMPLETED
Last Update Posted:
2010-10-26
First Post:
2009-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-25', 'studyFirstSubmitDate': '2009-07-24', 'studyFirstSubmitQcDate': '2009-07-24', 'lastUpdatePostDateStruct': {'date': '2010-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of collateral flow index (CFI, no unit) during exercise (E) compared to CFI at rest (R).', 'timeFrame': '6 minutes'}], 'secondaryOutcomes': [{'measure': 'Correlation of collateral flow index change and maximal workload.', 'timeFrame': '6 minutes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CAD', 'prompt physical exercise', 'collateral function'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '20584776', 'type': 'DERIVED', 'citation': 'Togni M, Gloekler S, Meier P, de Marchi SF, Rutz T, Steck H, Traupe T, Seiler C. Instantaneous coronary collateral function during supine bicycle exercise. Eur Heart J. 2010 Sep;31(17):2148-55. doi: 10.1093/eurheartj/ehq202. Epub 2010 Jun 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study in humans with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate if dynamic physical exercise leads to an instantaneous improvement of coronary collateral function.', 'detailedDescription': 'The existence of coronary collateral vessels and their benefit against cardiac events have been recognized for many years, but their functional capacity in response to physical exercise has partially remained elusive. Via endothelial shear stress, the fundamental stimulus for collateral development, exercise theoretically leads to collateral vasodilation and recruitment by an increase in heart rate and blood pressure during exercise. Moreover, the phenomenon of "walking through angina" indicates that collateral function and physical activity are related and their interaction is of clinical relevance.\n\nThe purpose of the present study in humans with stable coronary artery disease was to assess the instantaneous response of coronary collateral function to dynamic physical exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than or 18 years old\n* 1- to 3-vessel coronary artery disease (CAD)\n* Stable angina pectoris\n* At least 1 stenotic lesion suitable for PCI\n* Negative Allen-test\n* Written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Patients admitted as emergencies\n* Acute myocardial infarction\n* Unstable CAD\n* Q-wave myocardial infarction in the area undergoing CFI measurement\n* CAD treated best by CABG\n* Severe valve disease\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00947050', 'briefTitle': 'Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'Prompt Human Coronary Collateral Vasomotor Function Induced by Dynamic Physical Exercise', 'orgStudyIdInfo': {'id': '14/05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'rest first', 'description': 'rest first, cfi, exercise, cfi', 'interventionNames': ['Other: dynamic physical exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'exercise first', 'description': 'ex first', 'interventionNames': ['Other: dynamic physical exercise']}], 'interventions': [{'name': 'dynamic physical exercise', 'type': 'OTHER', 'otherNames': ['rest first', 'ex first'], 'description': 'dynamic supine bicycle exercise for 6 minutes', 'armGroupLabels': ['exercise first', 'rest first']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'University Hospital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Steffen Gloekler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bern'}, {'name': 'Mario Togni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bern'}, {'name': 'Pascal Meier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bern'}, {'name': 'Christian Seiler, MD,Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Bern'}, {'name': 'Stefano de Marchi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univerity of Bern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swiss National Science Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'University hospital Bern', 'oldOrganization': 'Cardiology'}}}}