Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-28 @ 7:31 AM
Study NCT ID:
NCT00885768
Status:
COMPLETED
Last Update Posted:
2011-05-13
First Post:
2008-07-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prevalence of Renal Artery Stenosis in Patients Referred for Cardiac Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012078', 'term': 'Renal Artery Obstruction'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'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': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002533', 'term': 'Cerebral Angiography'}], 'ancestors': [{'id': 'D009485', 'term': 'Neuroradiography'}, {'id': 'D059906', 'term': 'Neuroimaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000792', 'term': 'Angiography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'khatami@hbi.ir', 'phone': '00982161192659', 'title': 'Mohammad Reza Khatami MD', 'organization': 'Kidney Reasearch Center, Tehran University of Medical Sciences'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Renal Artery Stenosis', 'description': 'the patients with coronary artery stenosis who have also renal artery stenosis', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Prevalence of Renal Artery Stenosis (RAS)', 'timeFrame': '2 months', 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'The Number of Patients With Renal Artery Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Renal Artery Stenosis', 'description': 'the patients with coronary artery stenosis who have also renal artery stenosis'}], 'classes': [{'categories': [{'measurements': [{'value': '146', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3months', 'description': 'the prevalence of renal artery stenosis in patients with coronary artery disease', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Renal Artery Stenosis', 'description': 'the patients with coronary artery stenosis who have also renal artery stenosis'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'all patients with coronary artery stenosis on angiography entered the study', 'groupId': 'FG000', 'numSubjects': '146'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'all patients with including criteria completed the study', 'groupId': 'FG000', 'numSubjects': '146'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'all patients recruited during 4 months from April 2008 through July 2008 in Tehran Heart Center.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Renal Artery Stenosis', 'description': 'the patients with coronary artery stenosis who have also renal artery stenosis'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.17', 'spread': '9.47', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '95', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Iran, Islamic Republic of', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'the adult patients with coronary artry disease', 'classes': [{'title': '<=18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Between 18 and 65 years', 'categories': [{'measurements': [{'value': '127', 'groupId': 'BG000'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'when the reffered patients for coronary angiography have been proved to have significant coronary artery stenosis then the angiography of renal artery were performed.', 'unitOfMeasure': 'participants'}, {'title': 'the patients with coronary artery disease', 'classes': [{'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-11', 'studyFirstSubmitDate': '2008-07-11', 'resultsFirstSubmitDate': '2010-03-09', 'studyFirstSubmitQcDate': '2009-04-21', 'lastUpdatePostDateStruct': {'date': '2011-05-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-09', 'studyFirstPostDateStruct': {'date': '2009-04-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of Renal Artery Stenosis (RAS)', 'timeFrame': '2 months'}, {'measure': 'The Number of Patients With Renal Artery Stenosis', 'timeFrame': '3months', 'description': 'the prevalence of renal artery stenosis in patients with coronary artery disease'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['RAS(renal Artery Stenosis)', 'Atherosclerosis', 'angiography'], 'conditions': ['Renal Artery Stenosis']}, 'descriptionModule': {'briefSummary': 'All patients referred for coronary angiography will simultaneously be evaluated for renal artery stenosis and then stenosis more than 50% will be analyzed according to clinical conditions, risk factors and lab data.', 'detailedDescription': 'Renal Artery Stenosis (RAS) is a common finding in patients with generalized atherosclerosis. It is the cause of 15-20% of end stage renal disease in elderly patients. The prevalence of asymptomatic RAS in general population is unknown but it estimated to be 18% in 7th decade and more than 50% in the 8th. It is critical to find and manage the RAS before it\'s symptoms appear. The Gold standard for diagnosis of atherosclerotic arterial stenosis is angiography. In this study we will evaluate the prevalence, severity, location and related factors to renal artery stenosis in patients whom referred for coronary angiography in period of July-September in one of the most referral heart center in Iran, "The Tehran heart center" which is doing more than 50 coronary angiography daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients reffered to the Tehran Heart center for coronary angiography', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age more than 18 years\n\nExclusion Criteria:\n\n* contraindication to contrast use\n* not signing consent'}, 'identificationModule': {'nctId': 'NCT00885768', 'acronym': 'RAS', 'briefTitle': 'Prevalence of Renal Artery Stenosis in Patients Referred for Cardiac Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'Imam Khomeini Hospital'}, 'officialTitle': 'Prevalence of Renal Artery Stenosis in Patients Refered for Cardiac Catheterization to Heart Center Hospital in July-September 2008', 'orgStudyIdInfo': {'id': 'RAS001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'description': 'patients with renal artery stenosis', 'interventionNames': ['Procedure: angiography']}], 'interventions': [{'name': 'angiography', 'type': 'PROCEDURE', 'description': 'all patients undergoing coronary angiography with VISIPAQUE and if they had coronary stenosis then renal artery angiography will be done. the dose of contrast will be chosen according to renal function and clinical conditions which will be varied from 75 to 300 ml.', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Tehran Heart Center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imam Khomeini Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tehran Heart Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Mohammad Reza Khatami', 'oldOrganization': 'Kidney Research Center'}}}}