B VITAMIN ATHEROSCLEROSIS INTERVENTION TRAIL

描述(改编自应用程序)：虽然初级预防 战略将重点放在发展和发展的关键可改变风险因素上 动脉粥样硬化的进展，如高胆固醇血症，冠心病 在美国，疾病(CHD)仍然是主要的死亡原因。许多 出现动脉粥样硬化临床后遗症的患者没有 可识别的冠心病传统危险因素。流行病学研究 表明血浆tHcy水平与动脉粥样硬化有很强的相关性 童年降临到老年人。大量研究表明血浆总同型半胱氨酸 水平将成为CHD的独立风险因素，可通过以下方式轻松修改 维生素B、叶酸、维生素B12和维生素B6。血浆总同型半胱氨酸水平 在50岁后上升25%，这可能是与年龄相关的部分原因 患冠心病的风险。血浆总同型半胱氨酸水平的上升与年龄相关的下降同步 血清中的叶酸、维生素B12和维生素B6水平。提高了他们的水平 结果，即使这些维生素水平在正常到低正常范围内。 老年人似乎最容易发展为亚临床 维生素缺乏，因为这些B族维生素的饮食摄入量大约是 50岁后的每日价值的50%。低血清叶酸和维生素B6 血糖值与冠心病风险显著相关。因此，低维生素B 状态和血浆tHcy水平升高是高血压的重要危险因素 动脉硬化。证据，包括来自调查员实验室的数据 提示补充B族维生素可以减缓糖尿病的进展 健康人群中的亚临床动脉粥样硬化。因此， 研究人员提出了多点、随机、双盲、 用叶酸进行的为期2.5年的安慰剂对照动脉成像临床试验 健康男性服用5毫克维生素B12 20.4毫克和维生素B6 50毫克与安慰剂 女性40岁，低密度脂蛋白130 mg/dL，血浆总同型半胱氨酸8.5微克/升。 他们的目标是50%的老年人(2-60岁)，50%的妇女和50%的人 少数族裔主题。B族维生素对亚临床进展的影响 动脉粥样硬化将在几个血管床上进行非侵入性量化 用计算机图像处理的颈动脉B超图像 冠状动脉和腹主动脉内膜-中层厚度和EBCT。 补充维生素B可能会提供一种很有希望的方法来减少 动脉粥样硬化的进展，因为它是天然的，廉价的，高度 还可以，而且很安全。

DESCRIPTION (adapted from the application): Although primary prevention strategies have focused on key modifiable risk factors for development and progression of atherosclerosis, such as hypercholesterolemia, coronary heart disease (CHD) remains the leading cause of death in the United States. Many individuals who present with clinical sequelae of atherosclerosis do not have identifiable conventional risk factors for CHD. Epidemiological studies indicate a strong association of plasma tHcy levels with atherosclerosis from childhood to the elderly. A large number of studies have shown plasma tHcy levels to be an independent risk factor for CHD that is easily modifiable with the B-vitamins, folic acid, vitamin B12, and vitamin B6. Plasma tHcy levels rise 25 % after 50 years of age and may partially account for the age-related risk for CHD. The rise in plasma tHcy levels parallel the age-related decrease in serum levels of folate, vitamin B12, and vitamin B6. Elevated they levels result even with these vitamin levels in the normal to low-normal range. Elderly individuals seem to be most susceptible to development of subclinical vitamin deficiencies since dietary intake of these B-vitamins is approximately 50% the Daily Value after 50 years of age. Low serum folate and vitamin B6 levels are significantly associated with CHD risk. Therefore, low B-vitamin status and elevated plasma tHcy levels are important risk factors for atherosclerosis. Evidence, including data from the investigator's laboratory suggests that B-vitamin supplementation can reduce the progression of subclinical atherosclerosis in healthy individuals. Therefore, the investigators propose a multisite, randomized, double-blind, placebo-controlled, 2.5-year, arterial imaging clinical trial with folic acid 5 mg, vitamin B12 2 0.4 mg, and vitamin B6 50 mg versus placebo in healthy men and women >40 years old with LDL-C >130 mg/dL and plasma tHcy >8.5/micromol/L. They will target a cohort of 50% elderly (2-60 years old), 50 % women and 50 % minority subjects. The impact of B-vitamins on the progression of subclinical atherosclerosis will be noninvasively quantitated across several vascular beds with computer image processed B-mode ultrasonograms of carotid artery intima-media thickness and EBCT of the coronary arteries and abdominal aorta. B-vitamin supplementation may provide a promising approach for reducing the progression of atherosclerosis since it is natural, inexpensive, highly tolerable, and safe.