Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT00161005
Status:
UNKNOWN
Last Update Posted:
2009-04-17
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Norwegian Study on District Treatment of ST-Elevation Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2012-12-17', 'releaseDate': '2012-11-09'}, {'resetDate': '2015-06-05', 'releaseDate': '2015-05-18'}], 'estimatedResultsFirstSubmitDate': '2012-11-09'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 266}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-04-16', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2009-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death , myocardial infarction ,stroke or ischemia during 12 months.', 'timeFrame': '12 months'}, {'measure': 'Costs during 12 months.', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Size of infarction.', 'timeFrame': '3 months'}, {'measure': 'Complications', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute myocardial infarction', 'Fibrinolysis', 'Health effects /Quality of life'], 'conditions': ['Acute Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '24828790', 'type': 'DERIVED', 'citation': 'Bohmer E, Kristiansen IS, Arnesen H, Halvorsen S. Health-related quality of life after myocardial infarction, does choice of method make a difference? Scand Cardiovasc J. 2014 Aug;48(4):216-22. doi: 10.3109/14017431.2014.923581. Epub 2014 Jun 26.'}, {'pmid': '22607887', 'type': 'DERIVED', 'citation': 'Halvorsen S, Seljeflot I, Weiss T, Bohmer E, Arnesen H. Inflammatory and thrombotic markers in patients with ST-elevation myocardial infarction treated with thrombolysis and early PCI: a NORDISTEMI substudy. Thromb Res. 2012 Sep;130(3):495-500. doi: 10.1016/j.thromres.2012.04.016. Epub 2012 May 17.'}, {'pmid': '21450598', 'type': 'DERIVED', 'citation': 'Bohmer E, Kristiansen IS, Arnesen H, Halvorsen S. Health and cost consequences of early versus late invasive strategy after thrombolysis for acute myocardial infarction. Eur J Cardiovasc Prev Rehabil. 2011 Oct;18(5):717-23. doi: 10.1177/1741826711398425. Epub 2011 Feb 18.'}, {'pmid': '20598975', 'type': 'DERIVED', 'citation': 'Mistry N, Bohmer E, Hoffmann P, Muller C, Bjornerheim R, Kjeldsen SE, Halvorsen S. Left ventricular function in acute myocardial infarction treated with thrombolysis followed by early versus late invasive strategy. Am Heart J. 2010 Jul;160(1):73-9. doi: 10.1016/j.ahj.2010.04.011.'}, {'pmid': '19747792', 'type': 'DERIVED', 'citation': 'Bohmer E, Hoffmann P, Abdelnoor M, Arnesen H, Halvorsen S. Efficacy and safety of immediate angioplasty versus ischemia-guided management after thrombolysis in acute myocardial infarction in areas with very long transfer distances results of the NORDISTEMI (NORwegian study on DIstrict treatment of ST-elevation myocardial infarction). J Am Coll Cardiol. 2010 Jan 12;55(2):102-10. doi: 10.1016/j.jacc.2009.08.007. Epub 2009 Sep 10.'}, {'pmid': '17365975', 'type': 'DERIVED', 'citation': 'Bohmer E, Arnesen H, Abdelnoor M, Mangschau A, Hoffmann P, Halvorsen S. The NORwegian study on DIstrict treatment of ST-elevation myocardial infarction (NORDISTEMI). Scand Cardiovasc J. 2007 Jan;41(1):32-8. doi: 10.1080/14017430601153472.'}]}, 'descriptionModule': {'briefSummary': 'In the district areas of Norway patients with acute myocardial infarction with ST-elevation, are treated with thrombolysis. An increasing part of them receives thrombolysis before arrival to the local hospital.Usually these patients have been sent to an invasive center if thrombolysis fails or the patient gets ischemic symptoms during the stay.\n\nThis study will compare this strategy against immediate transportation to an invasive center after the patient has received thrombolysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Duration of painless than 6 hours.\n* ST-segment elevation of at least 0.1 mV in two or more extremity leads or at least 0.2 mV in two or more precordial leads.\n* The patient is getting thrombolysis.\n* Time to reach an invasive center is more than 1 hour.\n* Age 18-75 years.\n\nExclusion Criteria:\n\n* Known serious renal failure (creatinin \\> 250 mmol/l)\n* Pregnancy\n* Cardiogenic chock\n* Life threatening arrythmias\n* Other serious diseases with life expectancy less than 1 year.\n* Inability to perform an informed consent'}, 'identificationModule': {'nctId': 'NCT00161005', 'briefTitle': 'Norwegian Study on District Treatment of ST-Elevation Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Ullevaal University Hospital'}, 'officialTitle': 'Benefits and Costs in Two Different Strategies for Treating Acute Myocardial Infarction With ST-Elevation.', 'orgStudyIdInfo': {'id': '2935-0304 (UUS)'}, 'secondaryIdInfos': [{'id': '2004-162 (Helse Oest)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'PCI', 'type': 'PROCEDURE', 'description': 'Immediate transport to invasive center after thrombolysis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Ulleval University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Sigrun Halvorsen@uus.no, dr.med', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UUS, Oslo, Norway'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ullevaal University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helse Innlandet', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'dr.Sigrun Halvorsen', 'oldOrganization': 'Hjertemed avd., UUH'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2012-11-09', 'type': 'RELEASE'}, {'date': '2012-12-17', 'type': 'RESET'}, {'date': '2015-05-18', 'type': 'RELEASE'}, {'date': '2015-06-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Oslo University Hospital'}}}}