Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-01 @ 7:19 PM
Study NCT ID:
NCT00761969
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
2008-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prevention of Ischemic Events in Patients With Peripheral Arterial Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ales.blinc@kclj.si', 'phone': '+386 1 522 80 32', 'title': 'Ales Blinc, MD, DSc', 'organization': 'Department of Vascular Diseases, University of Ljubljana Med Ctr'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Death of all causes, non-fatal major ischemic events (myocardial infarction, ischemic stroke, critical limb ischemia) and revascularization procedures were recorded yearly for 5 years.', 'description': 'At the time of yearly follow-up, non-fatal major ischemic events and revascularization procedures in the previous year were recorded according to medical records. In case of a "no show" on a scheduled visit, subjects or their relatives and their family physician were actively contacted.', 'eventGroups': [{'id': 'EG000', 'title': 'Peripheral Arterial Disease', 'description': 'Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =\\< 0.90.\n\nImplementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).', 'otherNumAtRisk': 742, 'otherNumAffected': 284, 'seriousNumAtRisk': 742, 'seriousNumAffected': 195}, {'id': 'EG001', 'title': 'Control', 'description': 'Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD\n\nImplementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).', 'otherNumAtRisk': 713, 'otherNumAffected': 30, 'seriousNumAtRisk': 713, 'seriousNumAffected': 82}], 'otherEvents': [{'term': 'Peripheral arterial revascularization procedure', 'notes': 'Endovascular or surgical peripheral arterial revascularization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 742, 'numEvents': 183, 'numAffected': 183}, {'groupId': 'EG001', 'numAtRisk': 713, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary revascularization procedure', 'notes': 'Percutaneous coronary intervention or surgical coronary revascularization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 742, 'numEvents': 64, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 713, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Carotid revascularization', 'notes': 'Surgical carotid endarterectomy or carotid artery stenting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 742, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 713, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal aortic revascularization', 'notes': 'Surgical aortic repair or endovascular aortic repair (EVAR)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 742, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 713, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death of all causes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 742, 'numEvents': 112, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 713, 'numEvents': 47, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-fatal myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 742, 'numEvents': 50, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 713, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-fatal ischemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 742, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 713, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Critical limb ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 742, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 713, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Major Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}, {'value': '713', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peripheral Arterial Disease', 'description': 'Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =\\< 0.90.\n\nImplementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD\n\nImplementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).'}], 'classes': [{'title': 'Death of all causes', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}]}, {'title': 'Cardiovascular death', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Non-fatal myocardial infarction', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Non-fatal ischemic stroke', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Critical limb ischemia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Survival, major-event-free survival and event-free survival of patients with PAD and control subjects was estimated by the Kaplan-Meier method and compared by the log-rank test. The numbers of non-fatal events and revascularization procedures (which could be more than one per person) were compared using the Poisson regression - the outcome being the number of events per person-year.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '5 years:', 'description': 'Total number of deaths, cardiovascular deaths, non-fatal myocardial infarctions, ischemic strokes and critical limb ischemia.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Revascularization Procedures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'OG000'}, {'value': '713', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peripheral Arterial Disease', 'description': 'Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =\\< 0.90.\n\nImplementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD\n\nImplementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).'}], 'classes': [{'title': 'Peripheral arterial revascularization', 'categories': [{'measurements': [{'value': '183', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Coronary revascularization', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'carotid revascularization', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Abdominal aortic revascularization', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 years', 'description': 'Incidence of coronary, carotid and peripheral arterial revascularization procedures', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Peripheral Arterial Disease', 'description': 'Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =\\< 0.90.\n\nImplementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice .'}, {'id': 'FG001', 'title': 'Control', 'description': 'Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD\n\nImplementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice .'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '742'}, {'groupId': 'FG001', 'numSubjects': '713'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '542'}, {'groupId': 'FG001', 'numSubjects': '573'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '140'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '93'}]}]}], 'recruitmentDetails': 'This study was conducted by 85 primary care physicians-researchers from Slovenia, acountry with a population of about 2 million. Participating physicians were educated on cardiovascular disease prevention according to the European guidelines attended annual progress report meetings and were visited at least once a year by a study monitor.\n\n.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '742', 'groupId': 'BG000'}, {'value': '713', 'groupId': 'BG001'}, {'value': '1455', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Peripheral Arterial Disease', 'description': 'Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =\\< 0.90.\n\nImplementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).'}, {'id': 'BG001', 'title': 'Control', 'description': 'Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD\n\nImplementation of the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice: Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice (Eur Heart J 2003; 24: 1601-10, Eur J Cardiovasc Prev Rehabil. 2007;14 Suppl 2:S1-113).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.1', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '64.7', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '64.9', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '277', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '552', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '465', 'groupId': 'BG000'}, {'value': '438', 'groupId': 'BG001'}, {'value': '903', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Slovenia', 'categories': [{'measurements': [{'value': '742', 'groupId': 'BG000'}, {'value': '713', 'groupId': 'BG001'}, {'value': '1455', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood (16 ml) for analysis of inflammatory markers (from serum) and genotyping, to be correlated with clinical outcomes.\n\nAnonymity of patients is proveded by coding the samples and the patients clinical records.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1455}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-12', 'studyFirstSubmitDate': '2008-09-28', 'resultsFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2008-09-29', 'lastUpdatePostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-12', 'studyFirstPostDateStruct': {'date': '2008-09-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Major Cardiovascular Events', 'timeFrame': '5 years:', 'description': 'Total number of deaths, cardiovascular deaths, non-fatal myocardial infarctions, ischemic strokes and critical limb ischemia.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Revascularization Procedures', 'timeFrame': '5 years', 'description': 'Incidence of coronary, carotid and peripheral arterial revascularization procedures'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['peripheral arterial disease', 'secondary prevention', 'cardiovascular /atherothrombotic events', 'European guidelines', 'Cardiovascular disease prevention'], 'conditions': ['Peripheral Arterial Disease']}, 'referencesModule': {'references': [{'pmid': '1729621', 'type': 'BACKGROUND', 'citation': 'Criqui MH, Langer RD, Fronek A, Feigelson HS, Klauber MR, McCann TJ, Browner D. Mortality over a period of 10 years in patients with peripheral arterial disease. N Engl J Med. 1992 Feb 6;326(6):381-6. doi: 10.1056/NEJM199202063260605.'}, {'pmid': '10073955', 'type': 'BACKGROUND', 'citation': 'Newman AB, Shemanski L, Manolio TA, Cushman M, Mittelmark M, Polak JF, Powe NR, Siscovick D. Ankle-arm index as a predictor of cardiovascular disease and mortality in the Cardiovascular Health Study. The Cardiovascular Health Study Group. Arterioscler Thromb Vasc Biol. 1999 Mar;19(3):538-45. doi: 10.1161/01.atv.19.3.538.'}, {'pmid': '11560536', 'type': 'BACKGROUND', 'citation': 'Hirsch AT, Criqui MH, Treat-Jacobson D, Regensteiner JG, Creager MA, Olin JW, Krook SH, Hunninghake DB, Comerota AJ, Walsh ME, McDermott MM, Hiatt WR. Peripheral arterial disease detection, awareness, and treatment in primary care. JAMA. 2001 Sep 19;286(11):1317-24. doi: 10.1001/jama.286.11.1317.'}, {'pmid': '11786451', 'type': 'BACKGROUND', 'citation': "Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002 Jan 12;324(7329):71-86. doi: 10.1136/bmj.324.7329.71."}, {'pmid': '12114036', 'type': 'BACKGROUND', 'citation': 'Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002 Jul 6;360(9326):7-22. doi: 10.1016/S0140-6736(02)09327-3.'}, {'pmid': '10639539', 'type': 'BACKGROUND', 'citation': 'Heart Outcomes Prevention Evaluation Study Investigators; Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. N Engl J Med. 2000 Jan 20;342(3):145-53. doi: 10.1056/NEJM200001203420301.'}, {'pmid': '12964575', 'type': 'BACKGROUND', 'citation': 'De Backer G, Ambrosioni E, Borch-Johnsen K, Brotons C, Cifkova R, Dallongeville J, Ebrahim S, Faergeman O, Graham I, Mancia G, Manger Cats V, Orth-Gomer K, Perk J, Pyorala K, Rodicio JL, Sans S, Sansoy V, Sechtem U, Silber S, Thomsen T, Wood D; Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. European guidelines on cardiovascular disease prevention in clinical practice. Third Joint Task Force of European and Other Societies on Cardiovascular Disease Prevention in Clinical Practice. Eur Heart J. 2003 Sep;24(17):1601-10. doi: 10.1016/s0195-668x(03)00347-6. No abstract available.'}, {'pmid': '18091132', 'type': 'BACKGROUND', 'citation': 'Giampaoli S, Capewell S, Shelley E, Allender S, Briggs A, Jorgensen T, Labarthe D, Marques-Vidal P, Stegmayr B, Verschuren WM, Zdrojewski T. Foreword. Eur J Cardiovasc Prev Rehabil. 2007 Dec;14 Suppl 3:S1. doi: 10.1097/01.hjr.0000296928.40040.b0. No abstract available.'}, {'pmid': '27332992', 'type': 'DERIVED', 'citation': 'Blinc A, Kozak M, Sabovic M, Bozic Mijovski M, Stegnar M, Poredos P, Kravos A, Barbic-Zagar B, Stare J, Pohar Perme M. Survival and event-free survival of patients with peripheral arterial disease undergoing prevention of cardiovascular disease. Int Angiol. 2017 Jun;36(3):216-227. doi: 10.23736/S0392-9590.16.03731-7. Epub 2016 Jun 22.'}, {'pmid': '22233617', 'type': 'DERIVED', 'citation': 'Blinc A, Kozak M, Sabovic M, Bozic M, Stegnar M, Poredos P, Kravos A, Barbic-Zagar B, Pohar Perme M, Stare J; PID-PAB Investigators. Prevention of ischemic events in patients with peripheral arterial disease design, baseline characteristics and 2-year results an observational study. Int Angiol. 2011 Dec;30(6):555-66.'}]}, 'descriptionModule': {'briefSummary': 'The PID-PAB study aims to test the efficacy of the European Guidelines on Cardiovascular Disease Prevention in patients with peripheral arterial disease. Survival, the rate of major atherothrombotic events (myocardial infarction, stroke, critical limb ischemia) and the incidence of revascularization procedures will be compared between a group of patients with stable peripheral arterial disease (PAD) and age- and sex-matched control subjects without PAD. Both groups will be receiving up-to-date medical care according to their cardiovascular risk based on the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice. Yearly follow-up is planned for 5 years. The PID PAB study aims to test (a) whether stable PAD is still an adverse prognostic indicator in spite of contemporary preventive measures, and (b) to what extent do contemporary preventive measures improve the prognosis of patients with PAD in comparison to historic controls, representing the natural history of the disease.', 'detailedDescription': 'The observational study Prevention of Ischemic Events in Patients with Peripheral Arterial Disease by the European Guidelines on Cardiovascular Disease Prevention (Slovenian acronym of the study: PID-PAB)aims to test the efficacy of the European Guidelines on Cardiovascular Disease Prevention in patients with peripheral arterial disease, who have an even higher mortality rate than patients with isolated coronary artery disease or cerebrovascular disease when left to the natural course of the disease. The PID-PAB study will compare the rates of survival, major atherothrombotic events (myocardial infarction, stroke, critical limb ischemia) and revascularization procedures between a group of patients with stable peripheral arterial disease (PAD) and a control group of age- and sex-matched subjects without PAD. Both groups will be receiving up-to-date medical care (including life-style advice and prescription of cardioprotective medication) according their cardiovascular risk based on the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice. PAB is defined by a reduced ankle-brachial pressure index of =\\< 0.90, while absence of PAD is defined by palpable pedal pulses and a normal ankle-brachial index (0.91-1.30). Exclusion criteria are: age \\< 40 or \\> 80 years at inclusion, active cancer or other disease with a life expectancy of les than 5 years, any major atherothrombotic event in 30 days prior to enrollment, and pregnancy. All subjects will be followed annually for 5 years by comprehensive medical examinations. The settings of the study are primary care facilities in Slovenia, European Union. The target size of each group is 1000 subjects, i.e., 5000 patient years. The number of participating physicians-researchers is estimated at 100, with a goal for each physician to recruit 10 patients with PAD and 10 age- and sex-matched controls. The study is coordinated by a steering committee consisting of researchers from the Department of Vascular Diseases at the University of Ljubljana Medical Centre, Institute of Biomedical Informatics at the University of Ljubljana School of Medicine, Department of Family Medicine at the University of Ljubljana School of Medicine and the pharmaceutical company Krka, Slovenia, who is also the sponsor of the study. The protocol of the study has been approved by the Committee of Medical Ethics of the Republic of Slovenia.\n\nThe PID PAB study aims to answer the questions:\n\n1. Is stable PAD is still an adverse prognostic indicator in spite of contemporary preventive measures?\n2. To what extent do contemporary preventive measures improve the prognosis of patients with PAD in comparison to historic controls (described in earlier reports on the natural history of PAD ? We expect to still find a significant difference in the rate of cardiovascular events between patients with PAD and their peers without PAD, but we hypothesize that contemporary preventive measures will strongly attenuate the adverse prognosis of PAD regarding survival and major atherothrombotic events in comparison to the natural history of the disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with stable, objectively confirmed PAD, recruited from primary care settings in Slovenia, Europe.\n\nControl subjects of comparable age- and sex-distribution, without PAD, recruited from primary care settings in Slovenia, Europe.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with PAD: ankle-brachial pressure index \\<= 0.90\n2. Controls: palpable pedal pulses, ankle-brachial pressure index 0.91-1.30\n\nExclusion Criteria:\n\n1. Age \\< 40 or \\> 80 years at inclusion\n2. Malignancy with a life expectancy \\< 5 years\n3. Atherothrombotic event within a month before inclusion (acute coronary syndrome, stroke or documented transient ischemic attack, critical limb ischemia)\n4. pregnancy'}, 'identificationModule': {'nctId': 'NCT00761969', 'acronym': 'PID-PAB', 'briefTitle': 'Prevention of Ischemic Events in Patients With Peripheral Arterial Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'KRKA'}, 'officialTitle': 'Prevention of Ischemic Events in Patients With Peripheral Arterial Disease by the European Guidelines on Cardiovascular Disease Prevention in Clinical Practice', 'orgStudyIdInfo': {'id': 'PID-PAB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PAB', 'description': 'Subjects with stable peripheral arterial disease; ankle-brachial pressure index on at least one leg =\\< 0.90.', 'interventionNames': ['Other: Implementation of the European Guidelines on cardiovascular Disease Prevention in Clinical Practice']}, {'label': 'Control', 'description': 'Subjects without peripheral arterial disease (palpable pedal pulses and a normal ankle-brachial pressure index of 0.91-1.30), age- and sex-matched to the stuy group with PAD', 'interventionNames': ['Other: Implementation of the European Guidelines on cardiovascular Disease Prevention in Clinical Practice']}], 'interventions': [{'name': 'Implementation of the European Guidelines on cardiovascular Disease Prevention in Clinical Practice', 'type': 'OTHER', 'description': 'Life-style modification advice and prescribing standard cardioprotective medication (antiplatelet agents, statins, antihypertensive agents) according to the European Guidelines on Cardiovascular Disease Prevention in Clinical practice.', 'armGroupLabels': ['Control', 'PAB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Department of Vascular Diseases, University of Ljubljana Medical Center', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Ales Blinc, MD, DSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Vascular Diseases, University of Ljubljana Med Ctr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KRKA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University Medical Centre Ljubljana', 'class': 'OTHER'}, {'name': 'University of Ljubljana School of Medicine, Slovenia', 'class': 'OTHER'}, {'name': 'Krka, d.d., Novo mesto, Slovenia', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}