Stop Atherosclerosis in Native Diabetics study (SANDS)

描述(申请人提供)：尽管美国印第安人曾经受到心血管疾病(CVD)的保护，但现在他们的发病率高于普通美国人。大多数心血管疾病病例发生在患有糖尿病的个人身上。因此，当务之急是制定干预策略，以减少糖尿病患者的心血管疾病，并在这一人群中进行验证。这项建议是一项为期3年的随机试验，以检验强化降低低密度脂蛋白(目标小于或等于75毫克/分升)和强化降压(目标小于或等于115/75毫米汞)对心血管疾病的影响，并与通常小于或等于100毫克/分升和小于或等于130/85毫米汞的目标进行比较。之所以选择这些临界点，是因为在这一人群中，平均低密度脂蛋白和血压水平较低，但在低于当前目标的水平上，低密度脂蛋白、血压和心血管疾病之间存在很强的相关性。主要终点将是颈动脉内中膜厚度。次要终点将包括超声心动图、脂蛋白、蛋白尿和C反应蛋白(CRP)的心功能测量。这项研究将招募488名40岁以上的糖尿病美国印第安人男性和女性，并将在四个现场中心进行，这些中心包括亚利桑那州凤凰城/萨卡顿、亚利桑那州钦勒、南达科他州拉皮特城/松岭和俄克拉何马州劳顿的印第安人健康/部落初级保健机构，美国印第安人医生和社区成员提供了意见。研究结果将为发展以社区为基础的项目提供必要的证据，以治疗和预防美洲印第安人中的心血管疾病流行。这些数据还将有助于了解密集降低危险因素对美国所有人群中糖尿病患者动脉粥样硬化负担和心功能的影响，并为确定糖尿病患者的低密度脂蛋白和血压治疗目标提供证据。

DESCRIPTION (provided by applicant): Although once protected from cardiovascular disease (CVD), American Indians now have incidence rates higher than the general US population. The majority of CVD cases occur in individuals with diabetes. It is therefore imperative that intervention strategies to reduce CVD in diabetic individuals be developed and validated in this population. This proposal is for a randomized 3-year trial to examine the effects on CVD of intensive LDL reduction (goal less than or equal to 75 mg/dL) and intensive blood pressure lowering (goal less than or equal to 115/75 mmHg), compared to usual targets of less than or equal to 100 mg/dL and less than or equal to 130/85 mmHg. These cutpoints were chosen because mean LDL and blood pressure levels are lower in this population, but there is a strong relation between LDL, blood pressure, and CVD at levels below current targets. The primary endpoint will be carotid intimal-medial thickness. Secondary endpoints will include cardiac function measures by echocardiography, lipoproteins, albuminuria, and C-reactive protein (CRP). The study will enroll 488 diabetic American Indian men and women more than 40 years of age and will be conducted in four field centers involving Indian Health/Tribal primary care facilities in Phoenix/Sacaton, Arizona; Chinle, Arizona; Rapid City/Pine Ridge, South Dakota; and Lawton, Oklahoma, with input from American Indian physicians and community members. Study results will provide evidence needed to develop community-based programs to treat and prevent the epidemic of CVD among American Indians. The data will also be valuable in understanding the effects of intensive risk-factor reduction on atherosclerosis burden and cardiac function in diabetic individuals in all US populations and provide evidence for determining LDL and blood pressure treatment goals for diabetic patients.