Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-29 @ 9:26 AM
Study NCT ID:
NCT00954668
Status:
WITHDRAWN
Last Update Posted:
2018-07-06
First Post:
2009-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2009-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-03', 'studyFirstSubmitDate': '2009-08-06', 'studyFirstSubmitQcDate': '2009-08-06', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death and non-fatal recurrent infarction', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Composite of death, recurrent non-fatal myocardial infarction, refractory ischemia or target vessel re-vascularization', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-ST-elevation myocardial infarction', 'angiography', 'percutaneous coronary intervention', 'timing'], 'conditions': ['Non-ST-elevation Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Of estimated 140,000 cases of acute myocardial infarction admitted to hospitals in Germany per year, approximately 50% present with Non-ST-elevation myocardial infarction (NSTEMI). The currently available evidence led to current guideline recommendations that a systematic approach of immediate angiography in NSTEMI patients stabilized with contemporary antiplatelet treatment is not mandatory. However, this immediate invasive approach is appealing because it allows treating the underlying cause (the plaque rupture) as early as possible with subsequent reduction of death and recurrent myocardial infarction. In the IDEAL NSTEMI trial we test an immediate invasive approach (\\<2 h) with an approach 12-72 h according top guidelines with respect to 6 months death and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NSTEMI with\n\n * ischemic symptoms \\>10 minutes within 24 h\n * elevated troponin or creatine kinase above the upper limit of normal\n * ST-segment depression or transient ST-segment elevation, T-wave inversion\n * informed consent.\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* Age \\> 90 years\n* persistent angina\n* hemodynamic instability\n* overt congestive heart failure\n* life-threatening arrhythmias\n* STEMI\n* limited life-expectancy \\< 6 months\n* chronic oral anticoagulation\n* fibrinolysis \\< 48 hours\n* PCI \\< 14 days\n* contraindication for treatment with glycoprotein IIb/IIIa inhibitors, heparin, aspirin and clopidogrel\n* recent major trauma or surgery'}, 'identificationModule': {'nctId': 'NCT00954668', 'acronym': 'IDEAL NSTEMI', 'briefTitle': 'ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI)', 'orgStudyIdInfo': {'id': 'IDEAL NSTEMI 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'immediate angiography', 'description': 'Immediate invasive angiography \\< 2 h after randomization', 'interventionNames': ['Procedure: immediate angiography and revascularization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'early invasive angiography', 'description': 'early invasive angiography 12-72 h after randomization', 'interventionNames': ['Procedure: early invasive angiography']}], 'interventions': [{'name': 'immediate angiography and revascularization', 'type': 'PROCEDURE', 'description': 'immediate angiography \\< 2 hours after randomization', 'armGroupLabels': ['immediate angiography']}, {'name': 'early invasive angiography', 'type': 'PROCEDURE', 'description': 'early invasive angiography 12-72 h after randomization', 'armGroupLabels': ['early invasive angiography']}]}, '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', 'role': 'STUDY_CHAIR', 'affiliation': 'Heart Center Leipzig - University Hospital'}, {'name': 'Uwe Zeymer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut für Herzinfarktforschung'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stiftung Institut fuer Herzinfarktforschung', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor Prof. Dr. Holger Thiele', 'investigatorFullName': 'Holger Thiele', 'investigatorAffiliation': 'University of Leipzig'}}}}