Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT02938767
Status:
COMPLETED
Last Update Posted:
2016-10-20
First Post:
2016-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carotid Intima-media Thickness as Cardiovascular Mortality Predictor in Peritoneal Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'hemogram, serum creatinine, uric asid, calcium, phosphorus and albumin'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-19', 'studyFirstSubmitDate': '2016-10-17', 'studyFirstSubmitQcDate': '2016-10-18', 'lastUpdatePostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diseases morbidity', 'timeFrame': '10-15 years'}], 'secondaryOutcomes': [{'measure': 'Patient Survival', 'timeFrame': '10-15 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['peritoneal dialysis', 'carotid intima-media thickness', 'coronary flow reserve', 'cardiovascular mortality'], 'conditions': ['Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Cardiovascular (CV) disease is the main cause of death in patients on dialysis. The aim of this study is the long-term prognostic values of carotid intima-media thickness and coronary flow reserve in cardiovascular mortality of peritoneal dialysis patients.', 'detailedDescription': 'Endothelial dysfunction (ED) is a precursor and cause of cardiovascular diseases. Defining of endothelial thickness and coronary microvascular function could be useful for detecting ED. Endothelial dysfunction could be assessed by coronary flow reserve (CFR), carotid intima media thickness (IMT). Repeating measurement of IMT and CFR could be predictor of cardiovascular events and mortality in peritoneal dialysis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients were treated by peritoneal dialysis or followed up as kidney transplant recipient at the Istanbul Medical Faculty from October 1994 to October 2011. Two groups were established for trial as peritoneal dialysis patients and renal transplant recipients. Patients had follow up shorter than six months and missing data not included in the trial', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Peritoneal dialysis patients whose followed up at least six months from October 1994 to October 2011 (for study group)\n* Kidney transplant recipients whose followed up at least six months from October 1994 to October 2011 (for control group)\n\nExclusion Criteria:\n\n* diabetes mellitus\n* valvular heart disease,\n* any prior coronary intervention and congestive heart failure\n* Patients whose left anterior descending coronary artery (LAD) could not be visualized adequately by Doppler echocardiography were also excluded.'}, 'identificationModule': {'nctId': 'NCT02938767', 'briefTitle': 'Carotid Intima-media Thickness as Cardiovascular Mortality Predictor in Peritoneal Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Carotid Intima-media Thickness and Coronary Flow Reserve as Cardiovascular Event and Mortality Predictors in Peritoneal Dialysis Patients: Results of Seven-year Follow-up From a Single Center', 'orgStudyIdInfo': {'id': '3221'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'peritoneal dialysis patients', 'description': '37 peritoneal dialysis patients followed at the Istanbul Medical Faculty from October 1994 to October 2011'}, {'label': 'renal transplant recipients', 'description': '20 renal transplant recipients followed at the Istanbul Medical Faculty from October 1994 to October 2011 setted as the control group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Yasar Caliskan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine', 'investigatorFullName': 'Yasar Caliskan', 'investigatorAffiliation': 'Istanbul University'}}}}