Viewing Study NCT00161369



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Study NCT ID: NCT00161369
Status: COMPLETED
Last Update Posted: 2005-10-21
First Post: 2005-09-09

Brief Title: Effect of Homocysteine and Asymmetric Dimethylarginine on Cardiovascular Events in Hemodialysis Patients
Sponsor: University of Shizuoka
Organization: University of Shizuoka

Study Overview

Official Title: Contribution of Homocysteine and Asymmetric Dimethylarginine to Atherosclerosis and Cardiovascular Events in Maintenance Hemodialysis Patients
Status: COMPLETED
Status Verified Date: 2005-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None