BG Medicine Inc, Waltham, MA, USA.
Am Heart J. 2010 Jul;160(1):49-57.e1. doi: 10.1016/j.ahj.2010.02.021.
The identification of asymptomatic individuals at risk for near-term atherothrombotic events to ensure optimal preventive treatment remains a challenging goal. In the BioImage Study, novel approaches are tested in a typical health-plan population. Based on certain demographic and risk characteristics on file with Humana Inc, a total of 7,687 men 55 to 80 years of age and women 60 to 80 years of age without evidence of atherothrombotic disease but presumed to be at risk for near-term atherothrombotic events were enrolled between January 2008 and June 2009. Those who met the prespecified eligibility criteria were randomized to a telephonic health survey only (survey only: n = 865), standard risk assessment (Framingham only: n = 718), or comprehensive risk assessment in a dedicated mobile facility equipped with advanced imaging tools (n = 6,104). Baseline examination included assessment of cardiovascular risk factors and screening for subclinical (asymptomatic) atherosclerosis with quantification of coronary artery calcification by computed tomography (CT), measurement of intima-media thickness, presence of carotid atherosclerotic plaques and abdominal aortic aneurysm by ultrasound, and ankle brachial index. Participants with one or more abnormal screening test results underwent advanced imaging with contrast-enhanced magnetic resonance imaging for carotid and aortic plaques, contrast-enhanced coronary CT angiography for luminal stenosis and noncalcified plaques, and 18F-fluorodeoxyglucose-positron emission tomography/CT for carotid and aortic plaque inflammation. Plasma, PAXgene RNA, and DNA samples were obtained, frozen, and stored for future biomarker discovery studies. All individuals will be followed until 600 major atherothrombotic events have occurred in those undergoing imaging. The BioImage Study will help identify those patients with subclinical atherosclerosis who are at risk for near-term atherothrombotic events and enable a more personalized management of care.
在确保最佳预防治疗的情况下，识别有近期动脉血栓形成事件风险的无症状个体仍然是一个具有挑战性的目标。在 BioImage 研究中，新方法在典型的健康计划人群中进行了测试。根据 Humana Inc. 档案中的某些人口统计学和风险特征，共招募了 7687 名年龄在 55 至 80 岁之间的男性和年龄在 60 至 80 岁之间的女性，这些人没有动脉血栓形成疾病的证据，但被认为有近期动脉血栓形成事件的风险。这些人在 2008 年 1 月至 2009 年 6 月期间被纳入研究。符合预定入选标准的人被随机分为仅接受电话健康调查（仅调查组：n=865）、标准风险评估（仅 Framingham 组：n=718）或在配备先进成像工具的专用移动设施中进行综合风险评估（n=6104）。基线检查包括评估心血管危险因素和通过计算机断层扫描（CT）对亚临床（无症状）动脉粥样硬化进行筛查，测量血管内膜中层厚度，通过超声检测颈动脉粥样硬化斑块和腹主动脉瘤的存在，以及踝臂指数。一项研究结果显示，有一个或多个异常筛查结果的参与者接受了先进的影像学检查，包括颈动脉和主动脉斑块的对比增强磁共振成像、管腔狭窄和非钙化斑块的对比增强冠状动脉 CT 血管造影，以及颈动脉和主动脉斑块炎症的 18F-氟脱氧葡萄糖正电子发射断层扫描/CT。采集、冷冻并储存血浆、PAXgene RNA 和 DNA 样本，以备未来的生物标志物发现研究。所有参与者都将被随访，直到接受影像学检查的个体发生 600 例主要动脉血栓形成事件。BioImage 研究将有助于识别那些有亚临床动脉粥样硬化且有近期动脉血栓形成事件风险的患者，并实现更个性化的护理管理。
