Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT01236820
Status:
UNKNOWN
Last Update Posted:
2010-11-09
First Post:
2010-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Using L5 as a Risk Factor of Cardiovascular (CV) Disease in Chronic Renal and Dialytic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'lastUpdateSubmitDate': '2010-11-08', 'studyFirstSubmitDate': '2010-11-05', 'studyFirstSubmitQcDate': '2010-11-08', 'lastUpdatePostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-09', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['L5', 'LDL', 'Cardiovascular disease', 'Chronic kidney disease', 'Hemodialysis'], 'conditions': ['Cardiovascular Disease', 'Chronic Kidney Disease Patients', 'Hemodialytic Patients', 'High LDL Level', 'High L5 Level']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether L5, one of the Low Density Lipoproteins, is an effective predicting factor for cardiovascular disease in chronic renal and hemodialytic patients.', 'detailedDescription': 'Cardiovascular disease (CVD) is the most important cause of death of chronic kidney disease (CKD) and hemodialysis (HD) patients. Low Density Lipoprotein (LDL) is an essential indicator of CVD.The higher the plasma LDL level, the higher the risk of CVD. LDL is a heterogenous substance composed of different mass and size. Oxidized LDL (oxLDL) is the oxidation product of LDL and is the most important component of LDL associated with CVD. The oxLDL is mostly trapped within tissue and not easily to be detected from blood. L5 iw a kind of electronegative LDL and is associated with CVD in smokers and diabetic patients, even if these patients have normal plasma LDL. Uremia patients have lipid profile different from that of general people,while HD Patients have lower LDL and CKD patients have LDL higher than that of general population. Thus LDL plasma level cannot fully explain the high risk of CVD in CKD and HD patients. As patients with normal LDL but high L5 are prone to have CVD, we suspect there might be association of L5 with CVD in both CKD and HD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents in Taiwan, mostly in Taichung area', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of CKD\n* clinical diagnosis of HD\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT01236820', 'acronym': 'L5', 'briefTitle': 'A Study Using L5 as a Risk Factor of Cardiovascular (CV) Disease in Chronic Renal and Dialytic Patients', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'L5 as a Risk Factor of Cardiovascular Disease in Chronic Kidney Disease and Dialysis Patients', 'orgStudyIdInfo': {'id': 'CTCHANG001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal', 'description': 'Healthy population'}, {'label': 'CKD Patients', 'description': 'Chronic Kidney Disease, in Stage III-V'}, {'label': 'HD patients', 'description': 'End-stage renal disease patients undergoing hemodialysis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '404', 'city': 'Taichung', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chiu-Ching Huang, MD', 'role': 'CONTACT', 'email': 'cch@mail.cmuh.org.tw', 'phone': '886-4-22052121', 'phoneExt': '2902'}, {'name': 'Chiz-Tzung Chang, MD, Ph.D.', 'role': 'CONTACT', 'email': 'D19863@mail.cmuh.org.tw', 'phone': '886-4-22052121', 'phoneExt': '2902'}, {'name': 'Chiu-Ching Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Chiz-Tzung Chang, Ph.D.', 'role': 'CONTACT', 'email': 'D19863@mail.cmuh.org.tw', 'phone': '886-4-22052121', 'phoneExt': '2902'}, {'name': 'Chiu-Ching Huang, MD', 'role': 'CONTACT', 'email': 'cch@mail.cmuh.org.tw', 'phone': '886-4-22052121', 'phoneExt': '2902'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Chiu-Ching Huang', 'oldOrganization': 'China Medical University Hospital'}}}}