Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-02-04 @ 6:19 AM
Study NCT ID:
NCT02126202
Status:
UNKNOWN
Last Update Posted:
2014-04-29
First Post:
2014-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}, {'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}], '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': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, '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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-04-27', 'studyFirstSubmitDate': '2014-01-07', 'studyFirstSubmitQcDate': '2014-04-27', 'lastUpdatePostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with major adverse cardiac and cerebral events (the composite of death, myocardial infarction, urgent revascularisation, recurrent hospitalization due to cardiac reason and stroke).', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Number of participants with major bleeding', 'timeFrame': '1 month'}, {'measure': 'Number of participants with major adverse cardiac or cerebral event', 'timeFrame': '1 month'}, {'measure': 'Number of participants with minor bleeding', 'timeFrame': '1 month'}, {'measure': 'Number of participants with composite of cardiac death or myocardial infarction', 'timeFrame': '1 year'}, {'measure': 'Change from baseline of participants level of quality of life measured with the SF-36 questionnaire at 12 months', 'timeFrame': '1 year'}, {'measure': 'Change from baseline of participants level of angina pectoris at 12 months', 'timeFrame': '12 months'}, {'measure': 'Number of participants dead (all cause mortality)', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Elderly', 'Octogenarians', 'PCI', 'Myocardial infarction', 'NSTEMI', 'Unstable angina pectoris'], 'conditions': ['Non-ST Elevation Myocardial Infarction (NSTEMI)', 'Angina, Unstable']}, 'referencesModule': {'references': [{'pmid': '32586153', 'type': 'DERIVED', 'citation': 'Hirlekar G, Libungan B, Karlsson T, Back M, Herlitz J, Albertsson P. Percutaneous coronary intervention in the very elderly with NSTE-ACS: the randomized 80+ study. Scand Cardiovasc J. 2020 Oct;54(5):315-321. doi: 10.1080/14017431.2020.1781243. Epub 2020 Jun 26.'}, {'pmid': '25189626', 'type': 'DERIVED', 'citation': 'Libungan B, Hirlekar G, Albertsson P. Coronary angioplasty in octogenarians with emergent coronary syndromes: study protocol for a randomized controlled trial. Trials. 2014 Sep 4;15:349. doi: 10.1186/1745-6215-15-349.'}]}, 'descriptionModule': {'briefSummary': 'A multicenter, randomized clinical trial in elderly patients (over 80 years old) with unstable angina pectoris or Non-ST elevation myocardial infarction (NSTEMI).\n\nA total of 200 patients will be randomized to medical treatment (100 patients) or coronary angiography with revascularization if feasible (100 patients). Information regarding prior history, frailty, clinical presentation, in-hospital events, complications, angina, quality of life and mortality will be collected. Follow up time is 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '80 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. \\>80 years of age\n2. Acute coronary syndrome with ischemic symptoms (mainly chest pain) lasting over 10 minutes during the last 72 hours.\n\n AND at least one of the following:\n 1. ST-segment depression on ECG \\> 1mm\n 2. Elevated cardiac troponins\n3. Written informed consent before randomization\n\nExclusion criteria:\n\n1. Percutaneous coronary intervention (PCI) within 30 days prior to randomization\n2. Suspected ongoing active internal bleeding\n3. ST segment elevation of \\>1mm in two contiguous leads on ECG\n4. Enrollment in another study that has not completed the follow up phase.\n5. Known allergy to aspirin or clopidogrel\n6. Severe dementia\n7. Expected limited 1 year survival due to other disease(s)\n8. Unwillingness to participate in the trial or expected problems with compliance'}, 'identificationModule': {'nctId': 'NCT02126202', 'acronym': '80+', 'briefTitle': 'Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'Sahlgrenska University Hospital'}, 'officialTitle': 'Coronary Angioplasty in Octogenarians With Emergent Coronary Syndromes: The Octogenarians Study', 'orgStudyIdInfo': {'id': '80+'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conservative therapy', 'description': 'Optimized medical therapy'}, {'type': 'EXPERIMENTAL', 'label': 'Invasive therapy', 'description': 'Coronary angiography and revascularization if feasible', 'interventionNames': ['Procedure: Coronary angiography and revascularization if feasible']}], 'interventions': [{'name': 'Coronary angiography and revascularization if feasible', 'type': 'PROCEDURE', 'otherNames': ['Percutaneous coronary intervention (PCI)'], 'description': 'Coronary angiography and revascularization with PCI or CABG (coronary artery bypass grafting) if feasible', 'armGroupLabels': ['Invasive therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41345', 'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Berglind Libungan, MD', 'role': 'CONTACT', 'email': 'berglind.libungan@vgregion.se', 'phone': '+46313421000'}], 'facility': 'Department of Cardiology, Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'centralContacts': [{'name': 'Per A Albertsson, MD, PhD', 'role': 'CONTACT', 'email': 'per.albertsson@vgregion.se', 'phone': '+46313421000'}], 'overallOfficials': [{'name': 'Per A Albertsson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Cardiology', 'investigatorFullName': 'Per Albertsson', 'investigatorAffiliation': 'Sahlgrenska University Hospital'}}}}