Effects of Low Density Lipoprotein Apheresis on Oxidative Stress and Endothelial/Vascular Smooth Muscle Cell Function in Patients with Peripheral Arterial Disease and End-stage Renal Disease

UMIN ID: UMIN000000652

Registered date:01/11/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: peripheral artery disease, end-stage renal disease on hemodialysis
• Date of first enrollment: 2007/02/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: 1. Clinical papameters 1) Signs & symptoms (pain at rest, intermittent claudication, walking distance) 2) Blood biochemistry (serum lipid including total cholesterol and LDL, coaglatory factors including fibrinogen, CRP, oxidised LDL, MDA-LDL, AGE, VEGF, HGF). 3) ABI/baPWV 2. Vascular cell functions 1) Human vascular endothelial cells (commercially available) (ecNOS expression, proliferative activity, tube formation activity) 2) Human vascular smooth muscle cells (commercially available)(expressions of AT1 receptor and its interacting molecule ATRAP, growth factors, extracellular matrix, proliferation activity).

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: Exclusion criteria: 1. Poor controlled diabetics, 2. Poor controlled hypertensives, 3. Moderate to severe liver dysfunction, 4. Judged as unsuitable from other reasons.

Related Information

• Primary Sponsor: Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine
• Source(s) of Monetary Support: Department of Medical Science and Cardiorenal Medicine, Yokohama City University School of Medicine