PERIPHERAL ARTERIAL DISEASE

外周动脉疾病

• 批准号: 3646636
• 负责人: MARSHALL A ELAM
• 金额: $ 13.33万
• 依托单位: UNIVERSITY OF TENNESSEE HEALTH SCI CTR
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-09-30 至 1995-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3646636
• 关键词: antioxidants; cardiovascular disorder chemotherapy; clinical trials; combination chemotherapy; dosage; drug adverse effect; human subject; human therapy evaluation; lipid peroxides; low density lipoprotein; peripheral blood vessel disorder; warfarin

This contract is a part of a multicenter pilot study on 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 HDL-C level in the treatment group and equivalent reduction in LDL-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.

该合同是外周动脉多中心试点研究的一部分 疾病。 该临床试验的目的是评估可行性 外周病患者的多因素治疗方法 动脉疾病。 如果进行全面试验，其目的是 评估这些干预措施在减少心血管疾病方面的效果 外周动脉疾病患者的死亡率。 初级 研究的目的是： 1) 确定确切的类型和剂量 联合用药会导致 HDL-C 水平升高 治疗组和治疗中 LDL-C 水平的等效降低 组和治疗中 LDL-C 水平的同等降低 对照组； 2) 确定抗氧化剂在临床上是否合适 剂量改变患者血浆脂质过氧化物酶和氧化低密度脂蛋白水平 带PAD； 3）确定药物相互作用和不良反应 各种干预措施；特别是脂质修饰和 抗氧化药物对华法林患者凝血参数的影响； 4） 确定识别、招募和跟踪患者的可行性 来自各种医疗诊所（即戒烟诊所、 糖尿病诊所、外周血管诊所）。 研究人群应 由 600 名 PAD 患者组成，或者每个项目大约有 100 名参与者 六个临床中心。