SPECIMEN BASED ACCURACY OF CAROTID STENOSIS EVALUATION

描述（改编自申请人的摘要）：本发明的总体目标 该项目旨在提高成像研究的预测能力， 选择患者进行动脉内膜切除术。 内膜切除 手术已经被证明比使用医疗干预更有益 在治疗颈动脉狭窄的患者中， 导管注射X射线血管造影标准单独。 然而，预测 这些研究的效力相对较差。 该项目旨在 确定当前标准成像模态中的哪一个预测了 狭窄的程度和范围，最好的相关性的真实程度， 动脉粥样硬化性疾病 因此，该项目的主要目的是 确定目前使用的三种主要成像方法的准确性， 评估颈动脉分叉处的狭窄，即多普勒超声 导管血管造影和磁共振血管造影。 金本位 动脉内膜切除术将是评价这些模式的方法 手术时整块取出标本。 所有患者将接受检查， 三种方式中的每一种。 高分辨率三维磁共振成像 将获得切除标本的共振图像，以确定 每名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的减少， 最严重狭窄的位置。 每次成像的一致性 将确定对样本进行测量的研究。 审判 计划累积300例病例，其中所有三项成像研究都已完成。 手术前2个月内获得。 一些机构将 参加这次审判，以确保必要数量的 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， 联合或单独，最准确的预测颈动脉 狭窄 对颈动脉狭窄的更准确评估将 为颈动脉内膜切除术提供改进的患者选择。 这将减少手术的数量， 否则会被错误地评估为风险增加， 中风 与此同时，它将确保疾病的患者谁将 动脉内膜切除术的益处不可低估。 改善 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， 更好地选择患者进行手术。

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.