Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT00789451
Status:
COMPLETED
Last Update Posted:
2010-10-25
First Post:
2008-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Ischaemic-reperfusion on the Endogenous Fibrinolysis in Man
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': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-22', 'studyFirstSubmitDate': '2008-11-10', 'studyFirstSubmitQcDate': '2008-11-10', 'lastUpdatePostDateStruct': {'date': '2010-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Net t-PA release from the endothelium after ischaemia reperfusion', 'timeFrame': 'Throughout the study'}], 'secondaryOutcomes': [{'measure': 'Change in forearm blood flow after ischaemia reperfusion', 'timeFrame': 'throughout the study'}, {'measure': 'Change in platelet-monocyte-binding after ischaemia reperfusion', 'timeFrame': 'Throughout the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ischaemia reperfusion', 't-PA', 'Fibrinolysis', 'Endothelial function'], 'conditions': ['Ischaemic Heart Diseases']}, 'referencesModule': {'references': [{'pmid': '21083644', 'type': 'DERIVED', 'citation': 'Pedersen CM, Cruden NL, Schmidt MR, Lau C, Botker HE, Kharbanda RK, Newby DE. Remote ischemic preconditioning prevents systemic platelet activation associated with ischemia-reperfusion injury in humans. J Thromb Haemost. 2011 Feb;9(2):404-7. doi: 10.1111/j.1538-7836.2010.04142.x. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the heart. Current treatments are designed at relieving this blockage as quickly as possible to minimise 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 us 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, non-smokers.\n\nExclusion Criteria:\n\n* Any concurrent illness or chronic medical condition. Concurrent use of vasoactive medication. Smoking history.'}, 'identificationModule': {'nctId': 'NCT00789451', 'briefTitle': 'The Effect of Ischaemic-reperfusion on the Endogenous Fibrinolysis in Man', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'The Effect of Ischaemic-reperfusion on the Endogenous Fibrinolysis in Man', 'orgStudyIdInfo': {'id': 'CMP 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': '1', 'description': 'no ischaemia - only sham. Blood pressure cuff inflation up till 10 mmHg on the upper arm for 20 mins.', 'interventionNames': ['Procedure: Forearm vascular study']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Ischaemia 20 minutes. Blood pressure cuff will be inflated around the upper arm for 20 minutes to induce ischaemia.', 'interventionNames': ['Procedure: Forearm vascular study']}], 'interventions': [{'name': 'Forearm vascular study', 'type': 'PROCEDURE', 'description': 'Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of substance P (2,4,8 pmol/min). Venous blood sampling via cannula in antecubital fossa.', 'armGroupLabels': ['1', '2']}]}, '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'}}}}