Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-04-02 @ 4:48 AM
Study NCT ID:
NCT00514592
Status:
COMPLETED
Last Update Posted:
2013-10-23
First Post:
2007-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study (ANSYSCAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elias.johansson@neuro.umu.se', 'phone': '+46907850000', 'title': 'Dr Elias Johansson', 'organization': 'Umeå University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events not recorded other than the primary and secodary endpoint.', 'eventGroups': [{'id': 'EG000', 'title': 'All Patients', 'description': 'All patients enter the same group', 'otherNumAtRisk': 230, 'otherNumAffected': 0, 'seriousNumAtRisk': 230, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ipsilateral Ischemic Stroke Before Carotid Endarterectomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All patients enter the same group'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before CEA', 'description': 'Ipsilateral ischemic stroke after the presenting event. Only events that occurs within 90 days and before Carotid EndArterectomy (CEA) is used.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Any Stroke Before Carotid Enderarterectomy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'All patients enter the same group'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before CEA', 'description': 'Same as primary endpoint, but includes stroke of all types.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Patients', 'description': 'All patients enter the same group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Patients', 'description': 'All patients are in the same group'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '55', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '175', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '83', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '147', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-16', 'studyFirstSubmitDate': '2007-08-09', 'resultsFirstSubmitDate': '2013-07-08', 'studyFirstSubmitQcDate': '2007-08-09', 'lastUpdatePostDateStruct': {'date': '2013-10-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-07-08', 'studyFirstPostDateStruct': {'date': '2007-08-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ipsilateral Ischemic Stroke Before Carotid Endarterectomy', 'timeFrame': 'Before CEA', 'description': 'Ipsilateral ischemic stroke after the presenting event. Only events that occurs within 90 days and before Carotid EndArterectomy (CEA) is used.'}], 'secondaryOutcomes': [{'measure': 'Any Stroke Before Carotid Enderarterectomy', 'timeFrame': 'Before CEA', 'description': 'Same as primary endpoint, but includes stroke of all types.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Carotid stenosis', 'Carotid endarterectomy'], 'conditions': ['Carotid Stenoses']}, 'referencesModule': {'references': [{'pmid': '15043958', 'type': 'BACKGROUND', 'citation': 'Rothwell PM, Eliasziw M, Gutnikov SA, Warlow CP, Barnett HJ; Carotid Endarterectomy Trialists Collaboration. Endarterectomy for symptomatic carotid stenosis in relation to clinical subgroups and timing of surgery. Lancet. 2004 Mar 20;363(9413):915-24. doi: 10.1016/S0140-6736(04)15785-1.'}]}, 'descriptionModule': {'briefSummary': 'A single center observational study. Observing the time between cerebrovascular symptoms and Carotid Endarterectomy (CEA) and patient outcome. An intervention at 17 of the 29 study months aimed at reducing the delay and increasing the patient safety. Main outcome is to measure the reduction in recurrent stroke with decreased delay to CEA.', 'detailedDescription': 'All patients with a carotid stenosis \\>50% according to the NASCET-criteria are included. The study does not affect the health care the patients receive. The time between symptom and surgery is compared to the outcome of the CEA after 45 days, 6 months, 1 year and 5 years. An intervention in the form of new practical local and regional guidelines in January 2009 (#17 of the 29 study months) aimed at reducing the delay and increasing the patient safety.\n\nPRIMARY AIM:\n\nTo study the risk of Ipsilateral stroke, any stroke, death, any cerebrovascular event, any cardiovascular event.\n\nTwo primary analyses:\n\n1. Ipsilateral ischemic stroke within 90 Days of the presenting event. This analysis is aimed at the short term risk of pre-operative stroke. Survival analysis will be used. CEA will be used a censor, thus excluding all peri-operative and postoperative strokes.\n2. All primary endpoints within 5 years of the presenting event. This analysis is aimed att the long term risk of cardio-vascular morbidity and mortality.\n\nSecondary analyses:\n\n1\\) Same as first primary analysis, but including all stroke as endpoint, not only ipsilateral ischemic stroke.\n\nSECONDARY AIM:\n\nTo attempt to validate different risk and score systems already published by other sources. Such as can ABCD2-score be used safely to chose between acute and fast normal screening for carotid stenosis?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with a carotid stenosis \\>50%, preliminary eligable for CEA in the northern region of Sweden', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Carotid stenosis \\>50% according to NASCET criteria\n\nExclusion Criteria:\n\n* Not preliminary judged as having an indication for surgery, before an extensive investigation is launched. Thus, some patients that will not undergo CEA will be included.'}, 'identificationModule': {'nctId': 'NCT00514592', 'acronym': 'ANSYSCAP', 'briefTitle': 'Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study (ANSYSCAP)', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study', 'orgStudyIdInfo': {'id': 'EJ-0418'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All', 'description': 'All patients enter the same group', 'interventionNames': ['Other: New Guidelines']}], 'interventions': [{'name': 'New Guidelines', 'type': 'OTHER', 'description': 'New practical guidelines after half of the study aimed at reducing the delay and increasing the patient safety.', 'armGroupLabels': ['All']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90821', 'city': 'Umeå', 'state': 'Västerbotten County', 'country': 'Sweden', 'facility': 'University Hospital', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Per G Wester, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Elias Johansson', 'investigatorAffiliation': 'Umeå University'}}}}