Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
Study NCT ID:
NCT00907712
Status:
WITHDRAWN
Last Update Posted:
2015-06-23
First Post:
2009-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiovascular Assessment Before and After Limb Amputation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Department difficulties', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-21', 'studyFirstSubmitDate': '2009-05-18', 'studyFirstSubmitQcDate': '2009-05-21', 'lastUpdatePostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiovascular assessment', 'timeFrame': 'week'}], 'secondaryOutcomes': [{'measure': 'complications', 'timeFrame': 'month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['amputation', 'vascular', 'below knee', 'above knee', 'cardiovascular', 'echo', 'cardiovascular assessment'], 'conditions': ['Diagnostic Techniques, Cardiovascular']}, 'referencesModule': {'references': [{'pmid': '16505507', 'type': 'BACKGROUND', 'citation': 'Izumi Y, Satterfield K, Lee S, Harkless LB. Risk of reamputation in diabetic patients stratified by limb and level of amputation: a 10-year observation. Diabetes Care. 2006 Mar;29(3):566-70. doi: 10.2337/diacare.29.03.06.dc05-1992.'}, {'pmid': '19097667', 'type': 'BACKGROUND', 'citation': 'Izumi Y, Satterfield K, Lee S, Harkless LB, Lavery LA. Mortality of first-time amputees in diabetics: a 10-year observation. Diabetes Res Clin Pract. 2009 Jan;83(1):126-31. doi: 10.1016/j.diabres.2008.09.005. Epub 2008 Dec 20.'}, {'pmid': '19039278', 'type': 'BACKGROUND', 'citation': 'Remes L, Isoaho R, Vahlberg T, Hiekkanen H, Korhonen K, Viitanen M, Rautava P. Major lower extremity amputation in elderly patients with peripheral arterial disease: incidence and survival rates. Aging Clin Exp Res. 2008 Oct;20(5):385-93. doi: 10.1007/BF03325142.'}, {'pmid': '18413176', 'type': 'BACKGROUND', 'citation': 'Papazafiropoulou A, Tentolouris N, Soldatos RP, Liapis CD, Dounis E, Kostakis AG, Bastounis E, Katsilambros N. Mortality in diabetic and nondiabetic patients after amputations performed from 1996 to 2005 in a tertiary hospital population: a 3-year follow-up study. J Diabetes Complications. 2009 Jan-Feb;23(1):7-11. doi: 10.1016/j.jdiacomp.2007.11.008. Epub 2008 Apr 16.'}]}, 'descriptionModule': {'briefSummary': 'Vascular lower limb amputees have an increased morbidity and mortality. The aim of the study is to evaluate the hemodynamic changes after amputation and its relation to outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all vascular or diabetic patients before leg amputation\n\nExclusion Criteria:\n\n* traumatic amputation\n* sepsis patient\n* urgent surgery'}, 'identificationModule': {'nctId': 'NCT00907712', 'briefTitle': 'Cardiovascular Assessment Before and After Limb Amputation', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'orgStudyIdInfo': {'id': '10-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'cardiovascular', 'description': 'cardiac echo', 'interventionNames': ['Other: cardiac echo examination']}], 'interventions': [{'name': 'cardiac echo examination', 'type': 'OTHER', 'description': 'cardiac echo examination - before and after the surgery', 'armGroupLabels': ['cardiovascular']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Afula', 'country': 'Israel', 'facility': 'Haemek Medical Center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'orit semana', 'oldOrganization': 'HaEmek Medical Center, Israel'}}}}