Cornell ME/CFS CRC Clinical Core

康奈尔大学 ME/CFS CRC 临床核心

• 批准号: 10237221
• 负责人: Betsy A Keller
• 金额: $ 2.77万
• 依托单位: CORNELL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-30 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10237221
• 关键词: Accelerometer; Activities of Daily Living; Age; Aliquot; Anaerobic Threshold; Blood; Blood Pressure; Blood Tests; Blood specimen; Body mass index; California; Cardiopulmonary; Cells; Chronic Fatigue Syndrome; Clinical; Clinical Data; Code; Collection; Common Data Element; Communities; Complex; Congestive Heart Failure; Data; Data Analyses; Data Collection; Demographic Factors; Disease; Ensure; Environment; Environmental Risk Factor; Etiology; Exclusion; Exercise; Exercise Test; Exertion; Exhibits; Financial compensation; Freezing; Gender; Gene Expression; General Population; Health Professional; Heart Rate; Hour; Human Resources; Immune; Impairment; Individual; Learning; Los Angeles; Malaise; Measures; Medical History; Medical center; Medicine; Methods; Multiple Sclerosis; Nature; New York; New York City; Oxygen Consumption; Patients; Physical activity; Physicians; Physiological; Process; Production; Protocols documentation; Pulmonary Hypertension; Race; Recommendation; Reproducibility of Results; Research; Research Personnel; Research Project Grants; Sampling; Scanning; Site; Standardization; Surveys; Symptoms; Telephone; Testing; Ventilator; Work; Workload; college; disability; disabling symptom; extracellular vesicles; functional status; improved; inflammatory marker; lectures; negative affect; neuroimaging; outreach; patient screening; recruit; respiratory; rural area; screening; sedentary; stressor

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.

项目总结-临床核心 临床核心的职能是招募和筛选候选患者和对照受试者， 表征ME/CFS患者和匹配良好的对照受试者（例如，病史，ME/CFS常见 数据元素等）。ME/CFS的标志性症状是运动后不适（PEM），或运动后不适的加重。 患者在超过其独特阈值的运动后的综合症状。临床核心将获得 使用双CPET方案建立患者和对照的功能状态的生理数据 评估PEM对功能能力的影响。ME/CFS症状的增加通过标准化的 运动应激源为研究人员提供了一个独特的机会来评估PEM对患者的影响。 产生能量做功的能力。这需要两个连续的运动应激源， 运动试验（CPET），首先测量基线功能能力（最大能量产生）， 加重PEM症状，24小时后进行第二次测试，以测量运动对能量的影响 生产从CPET获得的生理数据将用于研究项目和 综合数据分析核心，检查与项目1的神经成像扫描结果的相关性， 来自项目2的细胞外囊泡含量、炎症标志物和代谢产物谱，以及基因 在项目3的免疫细胞中表达。临床核心将促进生理数据共享， 集成数据分析核心，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。临床中心将监督患者的测试 在两个州（纽约，加州）的三个不同地点进行对照，这两个州的人口统计学和 环境因素受试者将位于两个城市，但明显不同的环境（大新 约克市和洛杉矶）以及纽约州中部和西部的农村地区。研究患者 将加强我们的努力，以招募一个相对多样化的样本和探针网站- 特异性或环境因素是ME/CFS的病因。