Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT01171612
Status:
COMPLETED
Last Update Posted:
2016-04-07
First Post:
2010-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anna.r.pont@gmail.com', 'phone': '0034937231010', 'title': 'Anna Rodriguez-Pont', 'phoneExt': '21283', 'organization': 'Corporacion Sanitaria y Universitaria Parc Tauli'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This is a prospective and observational study'}}, 'adverseEventsModule': {'timeFrame': 'Perioperative events from surgery to 90 days after', 'description': 'We registered the adverse events from surgery to 90 days after All the events were included in our outcomes definitions', 'eventGroups': [{'id': 'EG000', 'title': 'Cardiac and Cerebrovascular Events', 'description': 'Adverse events registered independently related with antiplatelet therapy management', 'otherNumAtRisk': 432, 'otherNumAffected': 6, 'seriousNumAtRisk': 432, 'seriousNumAffected': 61}], 'otherEvents': [{'term': 'Stroke, Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 432, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deep Venous Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 432, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arterial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 432, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cardiac Arrest', 'notes': 'In hospital Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 432, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Death', 'notes': 'Death with cardiac origin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 432, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 432, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Unstable Angina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 432, 'numEvents': 39, 'numAffected': 39}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Significant Arrythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 432, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 432, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0.2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Major Adverse Cardiac and Cerebrovascular Events (MACCEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coronary Stent', 'description': 'Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 90 days after surgery', 'description': 'Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Major Haemorrhagic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Coronary Stent', 'description': 'Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 90 days after surgery', 'description': 'Transfusion \\> = 2 red blood cells Units, haemoglobin descent \\>= 20 gr/dL, intracerebral haemorrhage', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Adverse Events Related With Antiplatelet Therapy Management', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Not Withdrawal Antiplatelet Therapy', 'description': 'Patients wiht aspirin and/or clopidogrel withdrawal for 5 or more days'}, {'id': 'OG001', 'title': 'Incomplete Withdrawal (Mantaining ASA, Clopidogrel Withdrawn)', 'description': 'Patients under dual antiplatelet therapy, wich maintain aspirin, and withdrawn clopidogrel 5 or more days'}, {'id': 'OG002', 'title': 'Complete Withdrawal', 'description': 'patients with aspirin oand/or clopidogrel, which stopped therapy \\> 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000', 'lowerLimit': '0.733', 'upperLimit': '3.662'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '0.513', 'upperLimit': '2.299'}, {'value': '9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.479', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.086', 'ciLowerLimit': '0.513', 'ciUpperLimit': '2.299', 'groupDescription': 'Reference group were patients who maintained antiplatelet drugs (aspirin and/or clopidogrel) during the 4 days before surgery', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.479', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.638', 'ciLowerLimit': '0.733', 'ciUpperLimit': '3.662', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '90 days after surgery', 'description': 'Perioperative withdrawal antiplatelet therapy is defined with \\> or = 5 days without therapy\n\nWe create 3 categories:\n\n1. Not withdrawal\n2. Complete withdrawal (5 or \\> days without antiplatelet drugs , mono or dual therapy)\n3. Incomplete withdrawal: patients under dual antiplatelet therapy, who maintain aspirin and stopped clopidogrel =/ \\> 5 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MACCEs'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Coronary Stent', 'description': 'Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '483'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '432'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '51'}]}]}], 'recruitmentDetails': 'Observational, multicenter and prospective study, approved by the Ethics Committee. All patients with coronary stents undergoing noncardiac surgery with admission from February 2010 to April 2012 were the basis of the study.', 'preAssignmentDetails': 'Patients scheduled for noncardiac surgery with admission'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Coronary Stent', 'description': 'Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Between 18 and 70 years', 'categories': [{'measurements': [{'value': '219', 'groupId': 'BG000'}]}]}, {'title': '>70 years', 'categories': [{'measurements': [{'value': '213', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'age \\< or = 70 years old age \\> 70 years old', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '360', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '432', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '27.9', 'groupId': 'BG000', 'lowerLimit': '18.0', 'upperLimit': '50.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Kgm^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Antiplatelet Therapy', 'classes': [{'title': 'Antiplatelet therapy', 'categories': [{'measurements': [{'value': '412', 'groupId': 'BG000'}]}]}, {'title': 'Not antiplatelet therapy', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'patients taking previous aspirin, clopidogrel or both', 'unitOfMeasure': 'participants'}], 'populationDescription': '20 patienet were not taking previous antiplatelet agents'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 483}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-08', 'studyFirstSubmitDate': '2010-07-23', 'resultsFirstSubmitDate': '2013-08-13', 'studyFirstSubmitQcDate': '2010-07-27', 'lastUpdatePostDateStruct': {'date': '2016-04-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-09-16', 'studyFirstPostDateStruct': {'date': '2010-07-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiac and Cerebrovascular Events (MACCEs)', 'timeFrame': 'up to 90 days after surgery', 'description': 'Cardiac Mortality, Myocardial Infarction, Angina Pectoris, new arrythmia, Congestive Heart Failure, Stroke, Cardiac Arrest'}], 'secondaryOutcomes': [{'measure': 'Major Haemorrhagic Events', 'timeFrame': 'up to 90 days after surgery', 'description': 'Transfusion \\> = 2 red blood cells Units, haemoglobin descent \\>= 20 gr/dL, intracerebral haemorrhage'}, {'measure': 'Number of Patients With Adverse Events Related With Antiplatelet Therapy Management', 'timeFrame': '90 days after surgery', 'description': 'Perioperative withdrawal antiplatelet therapy is defined with \\> or = 5 days without therapy\n\nWe create 3 categories:\n\n1. Not withdrawal\n2. Complete withdrawal (5 or \\> days without antiplatelet drugs , mono or dual therapy)\n3. Incomplete withdrawal: patients under dual antiplatelet therapy, who maintain aspirin and stopped clopidogrel =/ \\> 5 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary Stent', 'BMS stent', 'DES stent', 'Date of stent implantation', 'cardiac event', 'neurovascular event', 'Bleeding', 'transfusion'], 'conditions': ['Acute Coronary Syndrome', 'Coronary Stent Occlusion', 'Surgery']}, 'referencesModule': {'references': [{'pmid': '29397139', 'type': 'DERIVED', 'citation': 'Rodriguez A, Guilera N, Mases A, Sierra P, Oliva JC, Colilles C; REGISTRESTENTS group. Management of antiplatelet therapy in patients with coronary stents undergoing noncardiac surgery: association with adverse events. Br J Anaesth. 2018 Jan;120(1):67-76. doi: 10.1016/j.bja.2017.11.012. Epub 2017 Nov 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate and monitor perioperative management of patients with coronary stents undergoing noncardiac surgery.\n\nObjectives:\n\n* To describe the incidence and severity of adverse cardiovascular events in patients with coronary stents undergoing noncardiac surgery with admission.\n* To assess the following-up of the guidelines about the perioperative management of antiplatelet therapy in these patients.\n* To assess the relationship between the incidence of cardiac or neurovascular events, as well as bleeding complications with the perioperative management of antiplatelet therapy.\n* Number of Participants with Adverse Events as a Measure of Safety', 'detailedDescription': '(Not desired)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary stents undergoing noncardiac surgery with admission between May 2010 and April 2012', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years old, with coronary stents\n* American Society of Anaesthesia physical status II-V\n* noncardiac surgery wiht admission\n* informed consent\n\nExclusion Criteria:\n\n* \\< 18 years old\n* American Society of Anaesthesia physical status I\n* ambulatory surgery\n* pregnancy\n* obstetric anaesthesia\n* endoscopic procedures\n* cardiac surgery\n* not informed consent'}, 'identificationModule': {'nctId': 'NCT01171612', 'acronym': 'RegistStents', 'briefTitle': 'Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Evaluation and Monitoring of Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery', 'orgStudyIdInfo': {'id': 'CIR2009017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronary Stent', 'description': 'Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Germans Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Municipal de Badalona', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Fundació Puigvert - IUNA', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínic', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Parc de Salut Mar-Esperança', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Parc de Salut Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Igualada', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Igualada', 'geoPoint': {'lat': 41.58098, 'lon': 1.6172}}, {'city': 'Mataró', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Mataró', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}, {'zip': '08208', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Sabadell. Corporació Sanitària Parc Taulí', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}, {'city': 'Sant Celoni', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Sant Celoni', 'geoPoint': {'lat': 41.68921, 'lon': 2.48965}}, {'city': 'Sant Cugat del Vallès', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Clínica ASEPEYO', 'geoPoint': {'lat': 41.47063, 'lon': 2.08611}}, {'city': 'Sant Joan Despí', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Sant Joan Despi Moisès Broggi', 'geoPoint': {'lat': 41.36718, 'lon': 2.0574}}, {'zip': '08221', 'city': 'Terrassa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Mútua de Terrassa', 'geoPoint': {'lat': 41.56667, 'lon': 2.01667}}], 'overallOfficials': [{'name': 'Anna Rodriguez-Pont, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corporacio Sanitaria Parc Tauli'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Anna Rodriguez Pont', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}