Ignite Creation Date:
2025-12-25 @ 3:57 AM
Ignite Modification Date:
2026-02-25 @ 4:14 AM
Study NCT ID:
NCT03759002
Status:
COMPLETED
Last Update Posted:
2018-11-29
First Post:
2018-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Mean Platelet Volume and Cardiovascular Disease in Children With End Stage Renal Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-28', 'studyFirstSubmitDate': '2018-11-22', 'studyFirstSubmitQcDate': '2018-11-28', 'lastUpdatePostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MPV in patients and controls', 'timeFrame': '1 year after study beginning', 'description': 'Comparing the mean of MPV in patients and controls.'}, {'measure': 'Echocardiographic indices in patients and controls', 'timeFrame': '1.5 years after study beginning', 'description': 'Comparing the means of echocardiographic indices in patients and controls'}, {'measure': 'Carotid intima media thickness in patients and controls', 'timeFrame': '2 years after study beginning', 'description': 'Comparing the mean of carotid intima media thickness in patients and controls'}, {'measure': 'Correlation between MPV and ejection fraction', 'timeFrame': '1.5 years after study beginning', 'description': 'Determining correlation between the value of MPV with ejection fraction in patients'}, {'measure': 'Correlation between MPV and left ventricular mass index', 'timeFrame': '1.5 years after study beginning', 'description': 'Determining correlation between the value of MPV with left ventricular mass index in patients'}, {'measure': 'Correlation between MPV and strain rate', 'timeFrame': '1.5 years after study beginning', 'description': 'Determining correlation between the value of MPV with strain rate in patients'}, {'measure': 'Correlation between MPV and global longitudinal strain', 'timeFrame': '1.5 years after study beginning', 'description': 'Determining correlation between the value of MPV with global longitudinal strain in patients'}, {'measure': 'Correlation between MPV and carotid intima media thickness', 'timeFrame': '2 years after study beginning', 'description': 'Determining correlation between the value of MPV with carotid intima media thickness in patients'}], 'secondaryOutcomes': [{'measure': 'MPV and thrombotic events', 'timeFrame': '2 years after study beginning', 'description': 'Comparing the values of MPV in patients with and without previous histories of thrombotic events including arteriovenous fistula thrombosis, cerebrovascular accident, deep venous thrombosis, and cerebrovascular accident'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Carotid Intimal Media Thickness', 'Left Ventricular Hypertrophy', 'Mean Platelet Volume', 'End Stage Renal Disease', 'Hemodialysis Complication', 'Peritoneal Dialysis Complication', 'Children']}, 'descriptionModule': {'briefSummary': 'Cardiovascular disease (CVD) is the major risk factor for death in end stage renal diseases (ESRD). Approximately 80% of ESRD patients have some degrees of left ventricular abnormalities at initiation of dialysis. Carotid intima media thickness (CIMT) has been widely accepted as an useful marker to assess CVD in ESRD children. In addition, cardiac mechanics parameters are used to evaluate cardiac function more precisely. However, measuring CIMT and cardiac mechanics parameters are expensive and difficult to perform as a routine method. Mean platelet volume (MPV) is a hematological index which shows the size of platelets. Uremic state causes inflammatory condition that affects MPV. Previous studies on people with normal renal function have shown that this parameter can also have association with CVD. However the data in children with ESRD is scarce. The aim of this study is to find a simple hematologic marker to use regularly in ESRD children finding patients at risk of CVD. Therefore, we will investigate the relationship between mean platelet volume and CIMT and cardiac mechanic parameters in children with ESRD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients group will be selected from children who referred to a tertiary care center of pediatric nephrology diseases.\n\nControls will be chosen from healthy volunteers who will be visited for medical routine examination in the hospital staff.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children under 18 years who have being dialyzed (hemodialysis or peritoneal dialysis) regularly more than 6 months, as case group.\n* Age and gender matched healthy children who have been referred for routine medical examination.\n\nExclusion Criteria:\n\n* Patients with uncontrolled hypertension (until being stabled)\n* Patients on any kind of antithrombotic agents or NSAIDs\n* Severe obesity\n* Diabetes patients\n* Patients with a past history of CVD or stroke in the last 6 months\n* Passive smokers who contacted daily with high smokers in their houses\n* Patients with known hematologic diseases or malignancies (such as Fanconi Anemia)\n* Uncontrolled hypothyroid or hyperthyroid patients\n* Patients with recent (in the last 4 weeks) catheter or exit -site infection.'}, 'identificationModule': {'nctId': 'NCT03759002', 'briefTitle': 'Association of Mean Platelet Volume and Cardiovascular Disease in Children With End Stage Renal Disease.', 'organization': {'class': 'OTHER', 'fullName': 'Isfahan University of Medical Sciences'}, 'officialTitle': 'Association Between Mean Platelet Volume With Echocardiographic Indices and Carotid Intima Media Thickness in Children With End Stage Renal Disease.', 'orgStudyIdInfo': {'id': '395723'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Children with end stage renal disease', 'interventionNames': ['Diagnostic Test: Imaging', 'Other: Blood sampling']}, {'label': 'Controls', 'description': 'Healthy sex- and age adjusted children', 'interventionNames': ['Diagnostic Test: Imaging', 'Other: Blood sampling']}], 'interventions': [{'name': 'Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Imaging including Echocardiography for determining cardiac indices (ejection fraction, left ventricular mass index, strain rate, global longitudinal strain) and Doppler ultrasound for measuring carotid intima media thickness', 'armGroupLabels': ['Controls', 'Patients']}, {'name': 'Blood sampling', 'type': 'OTHER', 'description': 'Blood sampling will performed on all participants for measuring hematological parameters including MPV.', 'armGroupLabels': ['Controls', 'Patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Alaleh Gheissari, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of pediatric nephrology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isfahan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical researcher', 'investigatorFullName': 'Amin Abedini', 'investigatorAffiliation': 'Isfahan University of Medical Sciences'}}}}