PERIPHERAL ARTERIAL DISEASE

外周动脉疾病

• 批准号: 2313548
• 负责人: KATHRYN A DAVIS
• 金额: $ 51.06万
• 依托单位: STATISTICS AND EPIDEMIOLOGY RES CORP
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-11-17 至 1995-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2313548
• 关键词: PERIPHERAL; ARTERIAL; DISEASE

This Contract is a part of a multicenter pilot study of peripheral arterial disease. The purpose of this clinical trial is to assess the feasibility of a multifactorial therapeutic approach in patients with peripheral arterial disease. The full-scale trial, if performed, is intended to assess the effect of these interventions in reducing cardiovascular mortality in patients with peripheral arterial disease. The primary objectives of the study are to: 1) determine the exact type and dosage of drug combination which would result in an increase in the HDL-C level in the treatment group and equivalent reductions in LDL-C level in the treatment and comparison groups: 2) determine if antioxidants in clinically appropriate doses alter plasma lipid peroxidase and oxidized LDL levels in patients with PAD; 3) determine the drug interactions and adverse effects of these various interventions: in particular, the effects of lipid-modifying and antioxidant drugs on coagulation parameters in patients on warfarin; 4) determine the feasibility of identifying, recruiting and following patients with PAD from a variety of medical clinics (i.e., stop smoking clinics, diabetic clinics, peripheral vascular clinics). The study population shall consist of 600 patients with PAD or approximately 100 participants in each of six Clinical Centers. This contract action is for the Coordinating Center effort.

该合同是外围多中心试点研究的一部分 动脉疾病。 该临床试验的目的是评估 多因素治疗方法的可行性 周围动脉疾病。 全面试验（如果执行）是 旨在评估这些干预措施减少的影响 外周动脉疾病患者的心血管死亡率。 研究的主要目标是：1）确定确切类型 和药物组合的剂量，这将导致增加 治疗组的HDL-C水平和LDL-C的同等降低 治疗和比较组的水平：2）确定是否是否 临床适当剂量的抗氧化剂改变血浆脂质 PAD患者的过氧化物酶和氧化的LDL水平； 3）确定 这些各种干预措施的药物相互作用和不利影响： 特别是，脂质修饰和抗氧化剂对 华法林患者的凝血参数； 4）确定 识别，招募和追随PAD患者的可行性 来自各种医疗诊所（即停止吸烟诊所，糖尿病患者 诊所，周围血管诊所）。 研究人群应 由600名PAD或大约100名参与者组成 六个临床中心中的每个。 此合同诉讼是针对的 协调中心工作。