Cornell ME/CFS CRC Clinical Core

项目摘要-临床核心 临床核心的职能是招募和筛选患者候选人和控制对象，并充分 确定ME/CFS患者和匹配的对照对象的特征(例如，病史、ME/CFS常见 数据元素等)。ME/CFS的一个显著症状是运动后不适(PEM)，或 患者在超过其独特阈值后的症状综合体。临床核心将获得 生理数据以确定使用双CPET方案的患者和对照组的功能状态 评估PEM对功能能力的影响。标准化的ME/CFS症状增加 运动应激源为研究人员提供了一个独特的机会来评估PEM对患者 产生能量做功的能力。这需要两个连续的运动应激源，使用心肺 运动试验(CPET)首先测量基线功能容量(最大能量产生)，然后 加剧PEM症状，并在24小时后进行第二次测试，以测量运动对能量的影响 制作。从CPET获得的生理数据将被研究项目和 综合数据分析核心，以检查与项目1的神经成像扫描结果的相关性， 来自项目2的细胞外小泡含量、炎症标志物和代谢物图谱，以及基因 在项目3的免疫细胞中表达。临床核心将促进将生理数据共享给 综合数据分析核心，允许对来自临床核心的数据进行全面分析 与研究项目中获得的其他数据相结合。临床核心将监督对患者的测试 在两个州(纽约州、加利福尼亚州)的三个不同地点进行控制，这两个州的人口统计和 环境因素。受试者将位于两个城市但截然不同的环境中(大新 纽约市和洛杉矶)以及纽约州中部和西部的农村地区。研究病人 来自不同环境的人将加强我们的努力，招募相对多样化的样本和探测点- 特殊或环境因素是ME/CFS的致病因素。

PROJECT SUMMARY – CLINICAL CORE The function of the Clinical Core is to recruit and screen patient candidates and control subjects and to fully characterize ME/CFS patients and well-matched control subjects (e.g., medical history, ME/CFS Common Data Elements, etc.). A hallmark symptom of ME/CFS is post-exertional malaise (PEM), or the exacerbation of a patient's symptom complex following exertion beyond their unique threshold. The Clinical Core will obtain physiological data to establish the functional status of both patients and controls using the two-CPET protocol to assess the effects of PEM on functional capacity. The increase of ME/CFS symptoms by a standardized exercise stressor provides researchers with a unique opportunity to evaluate the effects of PEM on a patient's ability to produce energy to do work. This requires two sequential exercise stressors using cardiopulmonary exercise tests (CPET) to first measure baseline functional capacity (maximum energy production) and to exacerbate PEM symptoms, and a second test 24 hours later to measure the effects of exertion on energy production. Physiological data obtained from the CPET will be utilized by the Research Projects and the Integrative Data Analysis Core to examine correlations with results of neuroimaging scans from Project 1, extracellular vesicle content, inflammatory markers and metabolite profiling from Project 2, and gene expression in immune cells from Project 3. The Clinical Core will facilitate sharing of physiological data to the Integrative Data Analysis Core to allow the comprehensive analysis of data from the Clinical Core in conjunction with other data acquired in the Research Projects. The Clinical Core will oversee testing of patients and controls at three different sites in two states (New York, California), which differ in demographics and environmental factors. Subjects will be located in two urban but distinctly different environments (greater New York City and Los Angeles) and in the rural areas of central and Western New York State. Studying patients from different environments will enhance our efforts to recruit a relatively diverse sample and probe site- specific or environment effects as etiologic factors of ME/CFS.