Personalised Medicine by using an Advanced Point-of-Care Tool for Stratified Treatment in High Risk Cardiovascular Patients (PoCCardio)

心血管疾病（CVD）是全球死亡的主要原因。除了确定的风险因素，如血压升高，血糖或血脂水平，循环蛋白质组学以及遗传标记物允许进一步分层的患者。虽然这些标志物中的一些可以在低门槛的医疗机构中进行常规测量，但其他标志物需要获得高度专业化和昂贵的实验室环境，这些环境通常只能在较大的三级环境中找到。该项目的目的是推进和定制最近在HORIZON 2020框架内开发的护理点（POINT OF CARE）工具。使用先进的芯片实验室（LoC）和微流体技术，该工具将进一步开发，以测量手指刺血中合格的生物标志物和多态性，以帮助识别，分类和监测高风险的心血管患者。这些生物标志物和生物标记工具的临床验证将在一项前瞻性、随机化的多国试验中进行，该试验将仅包括现有和批准的药物。根据合格生物标志物的特定模式，将患者分配至标准药物治疗或定制强化治疗。来自临床验证研究的数据将构成复杂AI计算分析的丰富来源，以探索主要和次要结局参数的潜在预测因子。该试验将进一步提供科学基础，以支持监管机构分别批准伴随诊断和药物处方建议。总体而言，该项目旨在通过先进的生物标志物驱动的基于POC的个性化药物来改善CVD患者的护理和治疗效果。为了实现这些目标，一个由五个学术研究伙伴和两个中小企业组成的平衡的财团聚集在一起。

Cardiovascular diseases (CVDs) are the leading cause of death worldwide. Besides established risk factors such as elevated blood pressure, blood glucose or lipid levels, circulating proteomic as well as genetic markers allow further stratification of patients. While some of these markers can be measured routinely in low-threshold healthcare institutions, others require access to highly specialized and costly laboratory environment which usually can be found only within larger tertiary settings. The aim of this project is to advance and tailor a point-of-care (PoC) tool, which was recently developed within the framework of HORIZON 2020. Using cutting-edge lab-on-a-chip (LoC) and microfluidic technology, the tool will be further developed to measure qualified biomarkers and polymorphisms from finger prick blood, in order to help identify, classify and monitor cardiovascular patients at high risk. The clinical validation of these biomarkers and the PoC tool will then be performed in a prospective, randomised multinational trial which will include only existing and approved pharmaceuticals. Based on their specific pattern of qualified biomarkers, patients will be assigned either to standard pharmacological treatment, or tailored intensified treatment. Data derived from the clinical validation study will constitute a rich source for complex AIpowered computational analysis to explore potential predictors for primary and secondary outcome parameters. The trial will further provide the scientific foundation to support regulatory authorities in regard to approval of companion diagnostics, and recommendations for the prescription of drugs, respectively. Overall, this project aims to improve care and treatment efficacy in CVD patients through an advanced biomarker-driven PoC-based personalised medicine. To achieve these aims, a well-balanced consortium of five academic research partners and two SMEs has been brought together.