Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT00359918
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2006-08-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-segment-Elevation MI (STEMI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005342', 'term': 'Fibrinolysis'}], 'ancestors': [{'id': 'D001777', 'term': 'Blood Coagulation'}, {'id': 'D006487', 'term': 'Hemostasis'}, {'id': 'D001790', 'term': 'Blood Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-21', 'studyFirstSubmitDate': '2006-08-01', 'studyFirstSubmitQcDate': '2006-08-01', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infarct size and microvascular obstruction assessed by MRI', 'timeFrame': '1-6 days'}], 'secondaryOutcomes': [{'measure': 'Clinical endpoints (bleeding, death, Re-MI, stroke)', 'timeFrame': '30 days'}, {'measure': 'ST-segment resolution', 'timeFrame': '90 min'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['infarction', 'facilitated PCI', 'primary PCI', 'infarct size', 'fibrinolysis', 'ST-elevation myocardial infarction (STEMI)'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '24962156', 'type': 'DERIVED', 'citation': 'de Waha S, Eitel I, Desch S, Fuernau G, Lurz P, Stiermaier T, Blazek S, Schuler G, Thiele H. Prognosis after ST-elevation myocardial infarction: a study on cardiac magnetic resonance imaging versus clinical routine. Trials. 2014 Jun 25;15:249. doi: 10.1186/1745-6215-15-249.'}, {'pmid': '21700245', 'type': 'DERIVED', 'citation': 'Thiele H, Eitel I, Meinberg C, Desch S, Leuschner A, Pfeiffer D, Hartmann A, Lotze U, Strauss W, Schuler G; LIPSIA-STEMI Trial Group. Randomized comparison of pre-hospital-initiated facilitated percutaneous coronary intervention versus primary percutaneous coronary intervention in acute myocardial infarction very early after symptom onset: the LIPSIA-STEMI trial (Leipzig immediate prehospital facilitated angioplasty in ST-segment myocardial infarction). JACC Cardiovasc Interv. 2011 Jun;4(6):605-14. doi: 10.1016/j.jcin.2011.01.013.'}]}, 'descriptionModule': {'briefSummary': 'Prehospital initiated facilitation of primary percutaneous coronary intervention by fibrinolysis might be helpful in re-opening the infarct related artery prior to percutaneous coronary intervention.\n\nThis studies tests the hypothesis that prehospital initiated facilitated PCI is superior to primary percutaneous coronary intervention with respect to infarct size.', 'detailedDescription': 'Patients with STEMI with symptoms \\< 3 hours are randomized in the region of Leipzig to either prehospital full-dose fibrinolysis (+ASA, Clopidogrel and heparin) with subsequent facilitated percutaneous coronary intervention or to primary percutaneous coronary intervention (after ASA + heparin + clopidogrel).\n\nPatients undergo cardiac magnetic resonance for assessment of infarct size early at day 1-4 after randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Angina pectoris \\< 3 hours\n* ST-elevation myocardial infarction\n\nExclusion Criteria:\n\n* Active bleeding\n* Active gastric ulcus\n* Previous stroke\n* Uncontrolled hypertension (\\> 200 mmHg)\n* Cerebral surgery \\< 8 weeks\n* Major surgery \\< 4 weeks\n* Malignancy\n* Treatment with coumarines\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00359918', 'acronym': 'LIPSIA STEMI', 'briefTitle': 'Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-segment-Elevation MI (STEMI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Randomized, Controlled Multicenter Trial of Prehospital Initiated Facilitated PCI Versus Primary PCI in Patients With STEMI LIPSIA-STEMI Trial', 'orgStudyIdInfo': {'id': 'Reg.-Nr. 008/2006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prehospital facilitated PCI', 'interventionNames': ['Drug: fibrinolysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Primary PCI', 'interventionNames': ['Procedure: Primary PCI']}], 'interventions': [{'name': 'fibrinolysis', 'type': 'DRUG', 'otherNames': ['Primary PCI'], 'description': 'Primary PCI', 'armGroupLabels': ['Prehospital facilitated PCI']}, {'name': 'Primary PCI', 'type': 'PROCEDURE', 'description': 'Primary PCI', 'armGroupLabels': ['Primary PCI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'University of Leipzig - Heart Center', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Holger Thiele, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Center Leipzig - University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Holger Thiele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Holger Thiele', 'investigatorAffiliation': 'University of Leipzig'}}}}