Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT00586950
Status:
COMPLETED
Last Update Posted:
2011-09-13
First Post:
2007-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
123I-BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-12', 'studyFirstSubmitDate': '2007-12-21', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2011-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Myocardial Free Fatty Acid metabolism', 'High risk patients', 'End-stage renal failure', 'Cardiovascular events', 'prognosis'], 'conditions': ['Coronary Disease', 'Fatty Acids, Unsaturated', 'Radioisotopes', 'Hemodialysis', 'Single Photon Emission Computed Tomography']}, 'descriptionModule': {'briefSummary': 'The aim of this multi-center study is to determine the applicability of BMIPP to diagnosing cardiac disease and to predicting the outcome of patients on hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Defined Population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Adult hemodialysis patients with one or more of the following 10 risk factors for coronary heart disease\n\n* Hypertension\n* Diabetes mellitus\n* Hyperlipidemia\n* Obliterative arteriosclerosis in the lower extremities\n* Smoker\n* Family history of juvenile coronary artery disease\n* History of ischemic stroke\n* History of heart failure requiring hospitalization\n* Within 3 months after initiation of hemodialysis therapy\n* Dialysis hypotension\n\nExclusion Criteria:Hemodialysis patients who meet any one of the following conditions will be excluded.\n\n* Peritoneal dialysis\n* Severe valvular disorder requiring treatment\n* Diagnosis of hypertrophic cardiomyopathy(HCM) or dilated cardiomyopathy(DCM) before start of dialysis\n* History of revascularization(PCI, CABG) or prior diagnosis of myocardial infarction\n* Hypersensitivity to BMIPP or its analogue\n* Judged unsuitable for the study for any other reasons by physicians.'}, 'identificationModule': {'nctId': 'NCT00586950', 'acronym': 'B-SAFE', 'briefTitle': '123I-BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan'}, 'officialTitle': 'Outcome Study on BMIPP SPECT Analysis for Decreasing Cardiac Events in Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'UHA_CAD05-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '135-8515', 'city': 'Meguro-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Toho University Ohashi Medical Center'}], 'overallOfficials': [{'name': 'Kenjiro Kikuchi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asahikawa Medical College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Toho University Ohashi Medical Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Kenjiro Kikuchi, MD, PhD , Principal Investigator', 'oldOrganization': 'Hokkaido Cardiovascular Hospital'}}}}