Validation of Imaging and Blood-based Small Vessel VCID Biomarkers in Multiethnic Population

多种族人群中影像学和基于血液的小血管 VCID 生物标志物的验证

• 批准号: 10369505
• 负责人: Amir H Kashani
• 金额: $ 262.38万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-30 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10369505
• 关键词: African American; American; Angiography; Area; Biological Markers; Blood; Blood capillaries; Blood specimen; California; Categories; Caucasians; Clinical; Clinical Data; Clinical Trials; Cognitive; Community Outreach; Data Analyses; Data Collection; Dementia; Development; Devices; Diffuse; Endothelium; Enrollment; Equipment; Evaluation; Eye; Eye diseases; FDA approved; Follow-Up Studies; Goals; Growth; Image; Impaired cognition; Inflammation; Infrastructure; Intervention; Laboratories; Latino; Latinx; Lead; Light; Liquid substance; Longitudinal Studies; Longitudinal cohort; Los Angeles; Magnetic Resonance Imaging; Minority Groups; National Institute of Neurological Disorders and Stroke; Optical Coherence Tomography; Participant; Phase; Pilot Projects; Plasma; Population; Population Heterogeneity; Protocols documentation; Public Health; Research; Research Personnel; Resolution; Signal Transduction; Site; Skeleton; Universities; Validation; Water; White Matter Hyperintensity; base; blood-based biomarker; candidate marker; candidate validation; cerebrovascular; clinical research site; cohort; density; design; exosome; human subject; in vivo; multi-ethnic; neurofilament; neuroimaging; non-invasive imaging; novel; programs; racial diversity; recruit; research study; retina blood vessel structure; retinal imaging; scale up; validation studies; vascular cognitive impairment and dementia

PROJECT SUMMARY/ABSTRACT The MarkVCID consortium was established in 2016 to pursue the initial stages of multi-site validation of 7 imaging-based and 4 fluid-based candidate biomarkers for small vessel vascular contributions to cognitive impairment and dementia (VCID). As one of the 7 participating sites, our team at the University of Southern California (USC) has analyzed and optimized candidate VCID biomarkers during the UH2 phase (years 1-2) and participated in the consortium-wide program of biomarker scaling-up, multi-site protocol implementation, and initial multi-site validation during the UH3 phase (years 3-5). USC has led the consortium-wide development and implementation of the optical coherence tomography angiography (OCTA) biomarker kit which is based on an FDA-approved device that allows in vivo and completely noninvasive imaging of retinal capillaries with a spatial resolution of ~10 microns. We have also participated in the validation of the other 6 MRI based candidate biomarkers while contributing blood samples for the validation of the 3 plasma-based candidate biomarkers. The primary objective of the next 5 years is to carry out comprehensive multi-site clinical validation of candidate VCID biomarkers in longitudinal studies of diverse populations that are typical in clinical settings in the US. Capitalizing on the high racial diversity in Los Angeles, we plan to enroll a multiethnic longitudinal cohort of at least 200 subjects that are enriched for small vessel VCID, including 100 Latinx subjects from the Los Angeles Latino Eye Study (LALES), 50 African Americans (AAs) enrolled in the African American Eye Disease Study (AFEDS), and 50 Caucasian participants from the Clinical Core of the USC ADRC. We have performed pilot studies in both Latinx and AA subjects (the two largest minority groups in the US) using MarkVCID protocols to show the feasibility of conducting such studies in a multiethnic cohort. We have also built a multiethnic team of investigators, technical staff, research coordinators, and community outreach staff to streamline enrollment, achieve the recruitment milestones, and perform longitudinal follow-up studies. Our team includes established expertise, equipment and infrastructure for OCTA, MRI, fluid biomarker and clinical/cognitive evaluation of VCID, as well as a proven track record in the sharing of de-identified clinical data through the Laboratory of Neuro Imaging (LONI) for the second phase of MarkVCID project.

项目摘要/摘要 MarkvcID联盟成立于2016年，旨在追求7种基于成像的基于成像和4个基于液体的候选生物标志物的多站点验证的初始阶段，用于对认知障碍和痴呆（VCID）的小血管血管贡献（VCID）。作为7个参与站点之一，我们的南加州大学（USC）的团队在UH2阶段（1-2年）分析了和优化的候选VCID生物标志物，并参加了BioMarker范围内的财团计划，在UH3阶段（在UH3阶段（3-5-5年3 - 5年）中，多智能协议实施，多站点协议实施，最初的多站点验证）。 USC领导了整个财团的开发和实施光学连贯性层析成像造影术（八八章）生物标志物试剂盒，该试剂盒基于FDA批准的设备，该设备允许体内和完全无创的视网膜毛细管成像，其空间分辨率为〜10微米。我们还参与了对其他6个基于MRI的候选生物标志物的验证，同时为3种基于等离子体的候选生物标志物的验证提供了血液样本。未来5年的主要目的是在美国临床环境中典型的不同种群的纵向研究中，对候选生物标志物进行全面的多站点临床验证。 Capitalizing on the high racial diversity in Los Angeles, we plan to enroll a multiethnic longitudinal cohort of at least 200 subjects that are enriched for small vessel VCID, including 100 Latinx subjects from the Los Angeles Latino Eye Study (LALES), 50 African Americans (AAs) enrolled in the African American Eye Disease Study (AFEDS), and 50 Caucasian participants from the Clinical Core of the USC ADRC。我们使用MarkVCID方案在拉丁裔和AA受试者（美国两个最大的少数群体）中进行了试点研究，以显示在多种族队列中进行此类研究的可行性。我们还建立了一个由调查人员，技术人员，研究协调员和社区外展人员组成的多民族团队，以简化入学率，实现招聘里程碑，并进行纵向后续研究。我们的团队包括八角中，MRI，流体生物标志物以及VCID的临床/认知评估的既定专业知识，设备和基础设施，以及通过Neuro Imaging（LONI）的第二阶段MarkVcID项目的Neuro Imaging（LONI）共享去识别的临床数据的可靠记录。