SPECIMEN BASED ACCURACY OF CAROTID STENOSIS EVALUATION

描述(改编自申请者摘要)：本报告的总体目标 项目是提高成像研究的预测能力，这些研究 选择患者进行动脉内膜剥脱术。动脉内膜剥脱术 手术已被证明比使用药物干预更有益。 在治疗颈动脉狭窄患者时 单纯导管注射X射线血管造影术标准。然而，预测性的 这些研究的力量相对较弱。这个项目的目的是 确定当前哪种标准成像方式可以预测 与真实范围最相关的狭窄程度和程度 动脉粥样硬化症。因此，该项目的主要目标是 确定当前使用的三种主要成像方法的准确性 颈动脉分叉部狭窄的超声评估 导管血管成像和磁共振血管成像。金本位 评估这些方式的标准将是动脉内膜切除术 手术时整块取出标本。所有患者都将接受 手术前三种模式中的每一种。高分辨率三维磁体 将获得切除标本的共振图像以确定 每个患者的实际狭窄程度。高分辨率数据将 进行分析，以确定管腔横截面积在 狭窄最严重的位置。每一种影像的一致性 从标本中进行测量的研究将被确定。这场审判 计划收集300例所有三项成像研究都已完成的病例 在手术前2个月内获得。几家机构将 参加这项试验，以确保所需数量的 可以招募受试者参加试验，并完成数据分析 在研究开始后的三年内。这项研究的结果将 确定从成像研究中提取的描述符在 联合或单独预测颈动脉最准确 狭窄。对颈动脉狭窄的更准确的评估将 为颈动脉内膜切除术的患者提供更好的选择。 这将减少对以下患者进行的手术数量 否则会被错误地评估为有更高的风险 卒中。同时，它将确保疾病患者将 动脉内膜剥脱术的好处并不被低估。改进了 诊断成像的预测价值将导致显著的 通过减少不必要的程序和通过 更合适的是选择病人做手术。

DESCRIPTION (Adapted from Applicant's Abstract): The overall goal of this project is to improve the predictive power of imaging studies that are performed to select patients for endarterectomy surgery. Endarterectomy surgery has been shown to be more beneficial than using medical intervention in treating patients with carotid artery stenosis determined on the basis of catheter injected X-ray angiography criteria alone. However, the predictive power of those studies is relatively poor. This project is intended to determine which of the current standard imaging modalities predicts the degree and extent of stenosis that best correlates with the true extent of atherosclerotic disease. The primary aim of this project is therefore to determine the accuracy of the three major Imaging methods currently used to assess stenosis at the carotid bifurcation, namely Doppler Ultrasound Catheter Angiography, and Magnetic Resonance Angiography. The gold standard by which these modalities will be evaluated will be the endarterectomy specimen removed en bloc at surgery. All patients will be examined with each of the three modalities prior to surgery. High resolution 3-D Magnetic Resonance images of the excised specimen will be obtained to determine the actual degree of stenosis for each patient. The high resolution data will be analyzed to determine the reduction of lumenal cross-sectional area at the location of the most severe stenosis. The agreement of each Imaging study with measurement from the specimen will be determined. The trial plans to accrue 300 cases in which all three imaging studies have been acquired within 2 months prior to surgery. Several institutions will participate in this trial in order to ensure that the requisite number of subjects can be recruited to the trial, and data analysis can be completed within three years of the study initiation. The results of this study will determine which descriptors extracted from the imaging studies provide, in combination or alone, the most accurate prediction of carotid artery stenosis. A more accurate assessment of carotid artery stenosis will provide improved selection of patients for carotid endarterectomy surgery. This will reduce the number of surgeries that are performed on patients who would otherwise be incorrectly assessed as being at increased risk for stroke. At the same time, it will ensure that disease in patients who will benefit from endarterectomy surgery is not underestimated. Improvements in the predictive value of diagnostic imaging will result in significant savings to the health care system by reducing unnecessary procedures, and by more appropriately selecting patients for surgery.