Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-29 @ 3:11 AM
Study NCT ID:
NCT01159366
Status:
COMPLETED
Last Update Posted:
2010-07-12
First Post:
2010-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incidence of Occluded Culprit Arteries and Impact of Coronary Collaterals on Outcome in Patients With NSTEMI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D054059', 'term': 'Coronary Occlusion'}], 'ancestors': [{'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'}, {'id': 'D003327', 'term': 'Coronary Disease'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062645', 'term': 'Percutaneous Coronary Intervention'}], 'ancestors': [{'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 602}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-09', 'studyFirstSubmitDate': '2010-07-08', 'studyFirstSubmitQcDate': '2010-07-08', 'lastUpdatePostDateStruct': {'date': '2010-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE', 'timeFrame': '6 months', 'description': 'composite of death, reinfarction and readmission for unstable angina within 6 months after inclusion'}], 'secondaryOutcomes': [{'measure': 'CK and CK-MB', 'timeFrame': '48 hours', 'description': 'Venous blood samples were taken at admission (baseline), and every 6 h subsequently for a period of 48 h.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['myocardial infarction', 'coronary occlusion', 'myocardial revascularization', 'collaterals', 'prognosis'], 'conditions': ['NSTEMI']}, 'descriptionModule': {'briefSummary': 'It is assumed that patients with non-ST-elevation myocardial infarctions (NSTEMI) showing an infero- or posterolateral occluded culprit artery (OCA) during diagnostic angiography frequently elude standard 12-lead electrocardiogram diagnosis. In addition, coronary collaterals may have beneficial effects in patients with OCA.', 'detailedDescription': 'We examined consecutive NSTEMI patients within 48 h of symptom onset. All patients underwent early invasive angiography plus optimal medical therapy. We compared baseline characteristics, procedural findings including analysis of TIMI-flow and collaterals using the Rentrop-classification, 30-day and 6-months major adverse cardiovascular events (MACE) in patients with and without totally OCA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 90 years,\n* onset of angina pectoris at rest \\<24 h or crescendo angina in recent weeks with symptoms under minimal exertion or at rest lasting \\<24 h,\n* elevated troponin T ≥0.03 µg/L and\n* written informed consent.\n\nExclusion Criteria:\n\n* persistent angina,\n* ST-segment elevation myocardial infarction (STEMI),\n* hemodynamic instability including cardiogenic shock,\n* oral anticoagulation therapy,\n* contraindications for glycoprotein IIb/IIIa inhibitors,\n* other disease with life expectancy \\<6 months,\n* known coagulopathy,\n* pregnancy,\n* other suspected causes of troponin elevation as myocarditis, secondary to hypertensive crisis, or after cardiac decompensation,\n* no ability to consent, and\n* participation in another study.'}, 'identificationModule': {'nctId': 'NCT01159366', 'briefTitle': 'Incidence of Occluded Culprit Arteries and Impact of Coronary Collaterals on Outcome in Patients With NSTEMI', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'Substudy of the Leipzig Immediate Versus Early and Late Percutaneous Coronary Intervention Trial in NSTEMI - LIPSIA-NSTEMI TRIAL', 'orgStudyIdInfo': {'id': 'NCT00402675'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'occluded culprit artery', 'description': 'An occluded lesion was defined as a lesion with 100% stenosis or TIMI-flow grade 0 or 1.', 'interventionNames': ['Procedure: percutaneous coronary intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'non-occluded culprit artery', 'description': 'A non-occluded lesion was defined as a lesion without 100% stenosis or TIMI-flow grade 0 or 1.', 'interventionNames': ['Procedure: percutaneous coronary intervention']}], 'interventions': [{'name': 'percutaneous coronary intervention', 'type': 'PROCEDURE', 'otherNames': ['early invasive treatment strategy in NSTEMI'], 'description': 'early timing', 'armGroupLabels': ['non-occluded culprit artery', 'occluded culprit artery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'University of Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Gerhard Schuler, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Leipzig'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jena', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Holger Thiele, MD, PhD', 'oldOrganization': 'University of Leipzig'}}}}