Core--Imaging

核心--影像

• 批准号: 7629073
• 负责人: MELVIN E CLOUSE
• 金额: $ 54.15万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7629073
• 关键词: Abdomen; Area; Arteries; Arteriographies; Atherosclerosis; Body Weight decreased; Body fat; Calcified; Calcium; Cardiovascular Diseases; Caring; Carotid Artery Ulcerating Plaque; Clinical; Clinical Investigator; Clinical Research; Coronary; Coronary Angiography; Coronary artery; Data; Deposition; Dietary Intervention; Disease regression; End Point; Fatty Change; Fatty acid glycerol esters; Fenofibrate; Future; Hepatic; High Density Lipoproteins; High Resolution Computed Tomography; Image; Imaging Techniques; Inflammation; Inflammatory; Intervention; Life Style; Lipids; Liver; Location; Measurement; Measures; Metabolic syndrome; Methodology; Modality; Nicotinic Acids; Obesity; Patients; Population; Prevention; Resolution; Risk Factors; Sample Size; Scanning; Standards of Weights and Measures; Techniques; Technology; Time; Trees; Variant; Vascular remodeling; Visceral; calcification; diet and exercise; new technology; subcutaneous

The function of the imaging core will be to optimize the methodology for reproducibly assessing both soft and calcified plaque in coronary arteries, as well as the assessment of abdominal and liver fat deposition using MDCT. This technology is currently being assessed as part of multi-center studies to compare MDCTA coronary arteriography to standard quantitative coronary angiography. These techniques will be applied to the clinical study population who are obese and have established CHD and meet criteria for the metabolic syndrome. The Imaging Core will be responsible for providing the clinical investigators with measurements of soft and calcified plaque and change in character or volume in the coronary tree as assessed by high resolution computed tomography using IV contrast, the amount of visceral fat and liver lipid as assessed by non contrast CT at baseline and after 30 months of treatment. The most important measure will be to assess the degree of vascular and plaque remodeling with this new technology over a 30 month period in the usual care group versus the other treatment groups. The primary endpoint in the clinical projects will be assessment of coronary soft plaque remodeling as determined by MDCTA at baseline and at 30 months. A secondary endpoint will be to assess change in the amount and location of calcification in plaque as it relates to progression, regression or stabilization. This CT modality without contrast material will also be used to assess total body (subcutaneous and visceral) and liver fat reduction or deposition. Estimated coefficients of variation for soft plaque (mean and SD volume 39 and 12 mm3) are 6%. We estimate progression of 5% in the usual care group and regression of up to 5% in the treatment groups, requiring a sample size of at least 202 subjects per intervention to attain a p<0.05. "Metabolic syndrome, inflammation and vascular remodeling", will evaluate the effect of three interventions: 1) life style (diet, exercise, weight loss); 2) HDL raising with niacin and fenofibrate; and 3) disalsid on progression, regression and stabilization of coronary artery plaque and inflammatory markers in patients with CHD and metabolic syndrome. An integral part of this SCCOR proposal is the Imaging Core which will enable the measurement of coronary artery calcified and non-calcified plaque burden, the accumulation or reduction of hepatic and total body fat using established quantifiable imaging techniques by the most advanced computed tomographic scanner . The spatial resolution of the scanner is 0.4mm and therefore creates pixels of 0.4mm2 and isotropic 0.4 mm voxels. The information gained from MDCT imaging could allow us to determine which risk factors are the most important for developing cardiovascular disease and would help direct future intervention strategies for prevention. The data from coronary artery calcium combined with CT coronary arteriographic studies could tell us whether the calcification that has increased in volume represents progression of calcification into new areas of non calcified plaque, indicating progression, or if the calcium increase is in a positively remodeled artery, suggesting that plaque burden is not increasing, therefore atherosclerosis is not progressing. The change in character and volume of non- calcified plaque over time is especially important to evaluate regression or stability, i.e., change from fatty to fibrous plaque or regression of fatty plaque on clinical projects by Shoelson and Welty may indicate the most appropriate dietary interventions and treatments to promote regression and/or stabilization. This type of information can also be obtained from total body and hepatic fat since the subjects will be followed longitudinally with repeat MDCTA scanning for calcified and noncalcified plaque, total body and hepatic fat content at 30 months.

成像核心的功能将是优化可重复评估的方法 冠状动脉中的软斑块和钙化斑块，以及腹部和肝脂肪的评估 使用MDCT沉积。目前正在评估这项技术，作为多中心研究的一部分 将MDCTA冠状动脉造影与标准定量冠状动脉造影进行比较。这些 技术将应用于肥胖并建立冠心病的临床研究人群 并符合代谢综合征的标准。成像核心将负责提供 临床研究人员，测量软斑块和性格或体积的变化 在高分辨率计算机断层扫描中使用静脉对比度评估的冠状树中， 基线时非对比度CT评估的内脏脂肪和肝脂质量以及30个月后 治疗。最重要的措施是评估血管和斑块重塑的程度 在通常的30个月内，这项新技术在通常的护理小组中与其他治疗 组。临床项目的主要终点将是评估冠状动脉软斑块 由MDCTA在基线和30个月时通过MDCTA确定的重塑。次要端点将是 评估与进展相关的菌株中钙化的数量和位置的变化， 回归或稳定。这种没有对比材料的CT模式也将用于评估总计 身体（皮下和内脏）和肝脂肪减少或沉积。估计的系数 软斑块的变化（平均值和SD体积39和12 mm3）为6％。我们估计的进展 在通常的护理组中为5％，治疗组的回归最高为5％，需要样本量 每次干预至少202名受试者达到p <0.05。 “代谢综合征，炎症和 血管重塑”，将评估三种干预措施的效果：1）生活方式（饮食，锻炼，体重 损失）; 2）用烟酸升高和fenobrate升高； 3）关于进展，回归和 冠心病和代谢患者的冠状动脉斑块和炎症标记的稳定 综合征。该SCCOR建议的组成部分是成像核心，该核心将使 测量冠状动脉钙化和非固定斑块负担，积累或 使用已建立的可量化成像技术减少肝和全身脂肪 高级计算机断层扫描仪。扫描仪的空间分辨率为0.4mm，因此产生的像素为0.4mm2和各向同性0.4 mm Voxels。从MDCT成像中获得的信息可以使我们能够确定哪种风险 因素对于发展心血管疾病最重要，将有助于指导未来 预防干预策略。来自冠状动脉钙的数据与CT结合 冠状动脉研究可以告诉我们钙化的体积是否增加 代表钙化发展为非钙化斑块的新区域，表明进展或 如果钙的增加是在积极重塑的动脉中，则表明斑块负担不是 增加，因此动脉粥样硬化没有进展。非 - 非字符和数量的变化 随着时间的推移，钙化斑块对于评估回归或稳定性尤为重要，即从 Shoelson和Welty在临床项目上对纤维斑块的脂肪或脂肪斑块的回归可能表明最多 适当的饮食干预措施和治疗，以促进回归和/或稳定。这类 也可以从总体和肝脂肪中获取信息，因为将遵循受试者 纵向进行钙化和非钙化斑块，总体和肝的重复扫描 30个月的脂肪含量。