Effect of Homocysteine and Asymmetric Dimethylarginine on Cardiovascular Events in Hemodialysis Patients
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|ClinicalTrials.gov Identifier: NCT00161369|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 21, 2005
|Condition or disease|
|Chronic Renal Failure Hemodialysis Atherosclerosis|
Objective- Homocysteine (Hcy) and asymmetric dimethylarginine (ADMA) have recently been recognized as potential risk factors for atherosclerosis in the general population, and the metabolism of each of these substances seems to be closely related. This study investigates the association between these substances, and whether elevated serum levels of Hcy and ADMA would be related to a high risk of atherosclerosis and cardiovascular events in maintenance hemodialysis (HD) patients.
Methods- The subjects were recruited from both day-time and night-time HD patients at Maruyama Hospital. The study inclusion criteria were those patients who had been receiving hemodialysis therapy for more than 6 months, were in a stable condition and were under 70 years old. The degree of atherosclerosis was evaluated by four indices involving the carotid artery intima-media thickness (IMT), carotid artery plaque, percentile of calcification index in the abdominal aortic wall (ACI) and elongation of the thoracic aorta. At the same time, plasma Hcy and ADMA were measured. After the initial laboratory examination and evaluation of the degree of atherosclerosis, all the patients were followed up for 5 years.
|Study Type :||Observational|
|Enrollment :||200 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||Contribution of Homocysteine and Asymmetric Dimethylarginine to Atherosclerosis and Cardiovascular Events in Maintenance Hemodialysis Patients|
|Study Start Date :||April 2000|
|Study Completion Date :||March 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00161369
|University of Shizuoka|
|Shizuoka, Japan, 422-8526|
|Study Chair:||Hiromichi Kumagai, MD||University of Shizuoka|