Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT00965120
Status:
COMPLETED
Last Update Posted:
2010-10-25
First Post:
2009-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065168', 'term': 'Bradykinin Receptor Antagonists'}, {'id': 'C065679', 'term': 'icatibant'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-22', 'studyFirstSubmitDate': '2009-08-21', 'studyFirstSubmitQcDate': '2009-08-24', 'lastUpdatePostDateStruct': {'date': '2010-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in forearm blood flow in response to vasodilators (ACh) and ischaemia reperfusion', 'timeFrame': '20 fixed timepoints during each study visit (3hrs)'}], 'secondaryOutcomes': [{'measure': 'Change in platelet-monocyte-binding after ischaemia reperfusion', 'timeFrame': '4 fixed timepoints during each study visit (3hrs)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ischaemia reperfusion', 'Bradykinin', 'Platelet activation', 'Endothelial function'], 'conditions': ['Ischaemic Heart Diseases']}, 'referencesModule': {'references': [{'pmid': '21873443', 'type': 'DERIVED', 'citation': 'Pedersen CM, Schmidt MR, Barnes G, Botker HE, Kharbanda RK, Newby DE, Cruden NL. Bradykinin does not mediate remote ischaemic preconditioning or ischaemia-reperfusion injury in vivo in man. Heart. 2011 Nov;97(22):1857-61. doi: 10.1136/heartjnl-2011-300323. Epub 2011 Aug 26.'}]}, 'descriptionModule': {'briefSummary': 'Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the heart. Current treatments are designed to relieve this blockage as quickly as possible to minimize damage to the heart muscle. However in restoring the supply of blood local damage known as "ischaemia-reperfusion injury" may occur. The aim of this study is to assess how clot forming and clot dissolving pathways are affected during this process, and examine the role of a natural inflammatory hormone, bradykinin. This will help the investigators to understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for heart attacks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy males between 18-65 years of ages\n* non-smokers\n\nExclusion Criteria:\n\n* any concurrent illness or chronic medical condition\n* concurrent use of vasoactive medication\n* smoking history'}, 'identificationModule': {'nctId': 'NCT00965120', 'briefTitle': 'The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'The Effect of Ischaemic-Reperfusion in Man - A Bradykinin Dependent Pathway', 'orgStudyIdInfo': {'id': 'CMP 3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Ischaemia 20 minutes. Blood pressure cuff will be inflated to 200mmHg around the upper arm for 20 minutes to induce ischaemia. Systemic infusion of placebo (saline).', 'interventionNames': ['Procedure: Forearm vascular study', 'Drug: Placebo (saline)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Ischaemia 20 minutes. Blood pressure cuff will be inflated to 200mmHg around the upper arm for 20 minutes to induce ischaemia. Systemic infusion of bradykinin receptor antagonist (HOE-140).', 'interventionNames': ['Procedure: Forearm vascular study', 'Drug: bradykinin receptor antagonist (HOE-140)']}], 'interventions': [{'name': 'Forearm vascular study', 'type': 'PROCEDURE', 'description': 'Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of vasodilators (Ach). Venous blood sampling via cannula in antecubital fossa.', 'armGroupLabels': ['1', '2']}, {'name': 'bradykinin receptor antagonist (HOE-140)', 'type': 'DRUG', 'description': 'Systemic infusion of bradykinin receptor antagonist (HOE-140).', 'armGroupLabels': ['2']}, {'name': 'Placebo (saline)', 'type': 'DRUG', 'description': 'Systemic infusion of placebo (saline).', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH16 4SB', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'University of Edinburgh, 49 Little France Crescent', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'David E Newby, PhD, FRCP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Edinburgh'}, {'name': 'Rajesh K Kharbanda, PhD, FRCP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Oxford'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Aarhus', 'class': 'OTHER'}, {'name': 'University of Oxford', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Christian M Pedersen, clinical research fellow', 'oldOrganization': 'University of Edinburgh'}}}}