Ancillary Study Data Analysis in VA-HIT

VA-HIT 中的辅助研究数据分析

• 批准号: 6434767
• 负责人: HANNA RUBINS
• 金额: $ 5.79万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-30 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6434767
• 关键词: acute phase protein; angiocardioultrasonography; atherosclerosis; blood chemistry; blood lipoprotein metabolism; cardiovascular disorder; chemoprevention; clinical research; disease /disorder proneness /risk; gemfibrozil; glucose tolerance; homocysteine; human data; insulin sensitivity /resistance; low density lipoprotein

The VA HDL Intervention trial (VA-HIT) was a multicenter, placebo controlled, randomized trial that showed that gemfibrozil significantly reduced major cardiovascular events in 2531 men with coronary heart disease, low levels of low density lipoprotein (LDL) cholesterol and low levels of high density lipoprotein (HDL) cholesterol. In addition to its unique lipid profile, the VA-HIT population also had a high prevalence of diabetes, impaired fasting glucose, or high fasting plasma insulin; central obesity; and hypertension, which are all components (together with high triglycerides and low ILL-cholesterol) of a constellation of risk factors known as the metabolic syndrome. Since prior clinical trials have not enrolled this type of population, the VA- HIT database is a unique resource. The purpose of the present proposal is to use this database to study additional risk markers that were measured in the study population. Specific proposed analyses are: 1. An analysis of the association between levels of glucose tolerance, insulin resistance and other features of the metabolic syndrome, occurrence of major cardiovascular outcomes, and gemfibrozil efficacy. 2. An analysis of the effect of gemfibrozil on progression of carotid atherosclerosis, as measured by B-mode ultrasound. 3. An analysis of the association between LDL particle size distribution and lipoprotein subclass distribution; homocysteine; lipoprotein(a); C- reactive protein, tissue plasminogen activator; fibrinogen; and factor VII; major cardiovascular outcomes, and gemfibrozil efficacy. Written documentation that the data will be available to us is included in the letter from Dr. Peter Peduzzi of the VA Cooperative Studies Program.

VA HDL干预试验（VA-HIT）是一项多中心，安慰剂对照，随机试验，表明吉菲布罗齐（Gemfibrozil）显着降低了2531名冠心病男性的主要心血管事件，低密度脂蛋白（LDL）糖浆（LDL）低密度脂肪蛋白和低密度Lipoprotototion Choloticin（HDL）的低密度脂肪蛋白（HDL）。除了其独特的脂质剖面外，VA HIT人群还具有较高的糖尿病患病率，禁食葡萄糖受损或空腹血浆胰岛素高；中央肥胖；和高血压，它们都是一组称为代谢综合征的危险因素的成分（以及高甘油三酸酯和低胆固醇）。由于先前的临床试验尚未招募此类人群，因此VA-HIT数据库是独特的资源。本提案的目的是使用该数据库研究研究人群中测量的其他风险标志物。具体提出的分析是：1。对葡萄糖耐量，胰岛素抵抗和代谢综合征的其他特征之间的关联，主要心血管结局的发生与吉菲贝罗齐疗效之间的关联。 2。通过B模式超声测量，对吉菲比罗齐对颈动脉粥样硬化进展的影响分析。 3。对LDL粒度分布与脂蛋白亚类分布之间的关联分析；同型半胱氨酸；脂蛋白（A）; C-反应性蛋白质，组织纤溶酶原激活剂；纤维蛋白原；和因子VII；主要的心血管结局和吉菲贝罗齐的功效。 VA合作研究计划的Peter Peduzzi博士的信中包括了将数据提供给我们的书面文档。