Timon Kuchler, Renate Hausinger, Matthias C Braunisch, Roman Günthner, Rebecca Wicklein, Benjamin Knier, Nathalie Bleidißel, Matthias Maier, Andrea Ribero, Maciej Lech, Kristina Adorjan, Hans Stubbe, Konstantin Kotilar, Uwe Heemann, Christoph Schmaderer
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This study protocol describes the \"All Eyes on PCS\" study, which aims to investigate the retinal microvasculature in PCS patients and COVID-19-recovered patients to provide new insights into the pathophysiology of PCS. \"All Eyes on PCS\" is a prospective, case-control study with the primary objective of detecting endothelial dysfunction (ED) in patients with PCS. Therefore, we intend to recruit patients with PCS, fully SARS-CoV-2-infection-recovered (CR) participants, and SARS-CoV-2-infection-naïve (CN) participants. Baseline measurements will include: (1) patient-specific characteristics, (2) biochemistry, (3) retinal vessel analysis (RVA), (4) survey questionnaires as patient-reported outcomes measurements (PROMs), (5) optical coherence tomography (OCT), OCT angiography (OCTA), and adaptive optics (AO), (6) blood pressure recordings, (7) handgrip strength test. 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引用次数: 0
摘要
由于广泛接种COVID-19疫苗,开发出有效的抗病毒药物,以及重症监护的COVID-19患者人数减少,SARS-CoV-2感染的风险似乎不那么具有威胁性。然而,研究表明,相当多的患者患有长期后遗症,甚至在感染SARS-CoV-2几个月后。所谓的“后冠状病毒综合征”(PCS)往往给医生的诊断和治疗带来挑战。本研究方案描述了“All Eyes on PCS”研究,旨在研究PCS患者和covid -19康复患者的视网膜微血管,为PCS的病理生理提供新的见解。“All Eyes on PCS”是一项前瞻性病例对照研究,主要目的是检测PCS患者的内皮功能障碍(ED)。因此,我们打算招募PCS患者、sars - cov -2感染完全康复(CR)的参与者和SARS-CoV-2-infection-naïve (CN)的参与者。基线测量将包括:(1)患者特异性特征,(2)生物化学,(3)视网膜血管分析(RVA),(4)调查问卷作为患者报告的结果测量(PROMs),(5)光学相干断层扫描(OCT), OCT血管造影(OCTA)和自适应光学(AO),(6)血压记录,(7)握力测试。6个月后,将在PCS队列中重复基线测量,1年后,将进行电话查询以评估残留症状和治疗需求。本研究的目的是深入了解PCS的病理生理学,为诊断和治疗提供客观的生物标志物,同时建立一个全面的PCS患者临床数据库。日期:2.12.2022。
All eyes on PCS: analysis of the retinal microvasculature in patients with post-COVID syndrome-study protocol of a 1 year prospective case-control study.
Since widespread vaccination against COVID-19, the development of effective antiviral drugs, and the decreasing number of patients with COVID-19 in intensive care, the risk from SARS-CoV-2 infection appears less threatening. However, studies show that a significant number of patients suffer from long-term sequelae, even months after SARS-CoV-2 infection. The so-called post-COVID syndrome (PCS) often presents a diagnostic and treatment challenge for physicians. This study protocol describes the "All Eyes on PCS" study, which aims to investigate the retinal microvasculature in PCS patients and COVID-19-recovered patients to provide new insights into the pathophysiology of PCS. "All Eyes on PCS" is a prospective, case-control study with the primary objective of detecting endothelial dysfunction (ED) in patients with PCS. Therefore, we intend to recruit patients with PCS, fully SARS-CoV-2-infection-recovered (CR) participants, and SARS-CoV-2-infection-naïve (CN) participants. Baseline measurements will include: (1) patient-specific characteristics, (2) biochemistry, (3) retinal vessel analysis (RVA), (4) survey questionnaires as patient-reported outcomes measurements (PROMs), (5) optical coherence tomography (OCT), OCT angiography (OCTA), and adaptive optics (AO), (6) blood pressure recordings, (7) handgrip strength test. After 6 months, baseline measurements will be repeated in the PCS cohort, and after 1 year, a telephone query will be conducted to assess residual symptoms and treatment needs. The aim of this study is to gain insight into the pathophysiology of PCS and to provide an objective biomarker for diagnosis and treatment, while also creating a comprehensive clinical database of PCS patients.ClinicalTrials.gov Identifier: NCT05635552; Date: 2.12.2022.
期刊介绍:
The original papers published in the European Archives of Psychiatry and Clinical Neuroscience deal with all aspects of psychiatry and related clinical neuroscience.
Clinical psychiatry, psychopathology, epidemiology as well as brain imaging, neuropathological, neurophysiological, neurochemical and moleculargenetic studies of psychiatric disorders are among the topics covered.
Thus both the clinician and the neuroscientist are provided with a handy source of information on important scientific developments.