Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-05 @ 6:36 PM
Study NCT ID:
NCT00192868
Status:
UNKNOWN
Last Update Posted:
2009-09-23
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction
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': 'D054855', 'term': 'Drug-Eluting Stents'}], 'ancestors': [{'id': 'D015607', 'term': 'Stents'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2011-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-09-22', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2009-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ST segment resolution', 'timeFrame': '90 min'}, {'measure': 'Late loss (difference between minimal lumen diameter in stented segment immediately after and at 8 month follow up).', 'timeFrame': 'immediately after and at 8 month follow up'}], 'secondaryOutcomes': [{'measure': 'Restenosis', 'timeFrame': '8 months'}, {'measure': 'maximal elevations in blood concentrations of CK-MB enzyme and troponin-T', 'timeFrame': 'Post procedure'}, {'measure': 'wall motion index', 'timeFrame': 'During hospitalisation: day 3-5'}, {'measure': 'Minimal lumen diameter', 'timeFrame': '8 months'}, {'measure': 'frequency of binary restenosis (>50% diameter stenosis), diameter stenosis (%) in the stented segment.', 'timeFrame': '8 months'}, {'measure': 'Occurrence of stent thrombosis and MACE.', 'timeFrame': '12 months'}]}, 'conditionsModule': {'keywords': ['primary PCI', 'distal protection', 'drug eluting stent', 'restenosis'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '20688033', 'type': 'DERIVED', 'citation': 'Kaltoft A, Kelbaek H, Thuesen L, Lassen JF, Clemmensen P, Klovgaard L, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Tilsted HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Terkelsen CJ, Helqvist S. Long-term outcome after drug-eluting versus bare-metal stent implantation in patients with ST-segment elevation myocardial infarction: 3-year follow-up of the randomized DEDICATION (Drug Elution and Distal Protection in Acute Myocardial Infarction) Trial. J Am Coll Cardiol. 2010 Aug 17;56(8):641-5. doi: 10.1016/j.jacc.2010.05.009.'}, {'pmid': '20185036', 'type': 'DERIVED', 'citation': 'Kaltoft A, Kelbaek H, Klovgaard L, Terkelsen CJ, Clemmensen P, Helqvist S, Lassen JF, Thuesen L. Increased rate of stent thrombosis and target lesion revascularization after filter protection in primary percutaneous coronary intervention for ST-segment elevation myocardial infarction: 15-month follow-up of the DEDICATION (Drug Elution and Distal Protection in ST Elevation Myocardial Infarction) trial. J Am Coll Cardiol. 2010 Mar 2;55(9):867-71. doi: 10.1016/j.jacc.2009.09.052.'}, {'pmid': '18725489', 'type': 'DERIVED', 'citation': 'Kelbaek H, Thuesen L, Helqvist S, Clemmensen P, Klovgaard L, Kaltoft A, Andersen B, Thuesen H, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Hansen HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Terkelsen CJ, Lassen JF; DEDICATION Investigators. Drug-eluting versus bare metal stents in patients with st-segment-elevation myocardial infarction: eight-month follow-up in the Drug Elution and Distal Protection in Acute Myocardial Infarction (DEDICATION) trial. Circulation. 2008 Sep 9;118(11):1155-62. doi: 10.1161/CIRCULATIONAHA.107.758698. Epub 2008 Aug 25.'}, {'pmid': '18308157', 'type': 'DERIVED', 'citation': 'Kelbaek H, Terkelsen CJ, Helqvist S, Lassen JF, Clemmensen P, Klovgaard L, Kaltoft A, Engstrom T, Botker HE, Saunamaki K, Krusell LR, Jorgensen E, Hansen HH, Christiansen EH, Ravkilde J, Kober L, Kofoed KF, Thuesen L. Randomized comparison of distal protection versus conventional treatment in primary percutaneous coronary intervention: the drug elution and distal protection in ST-elevation myocardial infarction (DEDICATION) trial. J Am Coll Cardiol. 2008 Mar 4;51(9):899-905. doi: 10.1016/j.jacc.2007.10.047.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical, echocardiographic and angiographic outcome of distal protection in the infarct related coronary artery and implantation of drug eluting versus bare metal stents in patients with ST-elevation myocardial infarctions treated acutely with percutaneous coronary intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Acute onset typical chest pain of \\< 12 hours' duration\n* ST-elevation of \\> 4 mm (1mm = 0.1 mV) in contiguous leads of the electrocardiogram\n* High grade stenosis or occlusion of a native major coronary artery that can be crossed with a soft or intermediate tip guidewire\n* Possibility to perform distal protection of the infarct-related artery\n\nExclusion Criteria:\n\n* History of previous myocardial infarction\n* Use of fibrinolytic agents for the index infarction\n* Left main stenosis\n* Heavily calcification of abdominal aorta or occlusive iliofemoral disease hampering access to the coronary ostias by the femoral route\n* Known renal failure\n* Other significant cardiac disease\n* Other severe disease with an expected survival \\< 1 year\n* Known allergy against clopidogrel or contrast media that can not be avoided/limited by medication\n* Linguistic difficulties needing an interpreter\n* Gastrointestinal bleeding within 1 month\n* Childbearing potential or pregnancy\n* Participation in another study"}, 'identificationModule': {'nctId': 'NCT00192868', 'briefTitle': 'Drug Elution and Distal Protection During Percutaneous Coronary Intervention in ST Elevation Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Drug Elution and DIstal Protection During Percutaneous CoronAry Intervention in sT Elevation Myocardial InfarctiON. Acronym: Dedication', 'orgStudyIdInfo': {'id': 'DEDICATION'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Distal protection and drug eluting stent', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Cardiac Cath Lab, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Henning Kelbaek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}}}}