Evaluation of a Prognostic Model for Chagas Primary Care Setting

慢性恰加斯病(CCC)是一种潜在的致命疾病，但疾病的严重程度差异很大，准确划分疾病进展和死亡的风险仍然是一个悬而未决的挑战。虽然有复杂的预后评分，但缺乏一种简单、低成本和易于使用的、适用于初级保健环境的预后模型。该项目的第一个假设是，可以开发一种基于简单的心电测量结合临床信息和脑钠素(BNP)水平的预后算法，该算法将准确预测CCC患者的疾病进展和死亡风险，并在临床实践中有用。因此，我们的目标是开发和测试一种简单的预测算法来确定CCC患者的预后。为了实现这一目标，将根据旨在支持米纳斯吉拉斯州初级保健的远程保健计划，建立一大批受感染的患者。我们将招募2000名CCC患者参加这项队列研究，并对他们进行至少两年的跟踪调查，以开发和验证这一简单的预后算法。然而，我们认识到CCC具有复杂的生理病理机制，许多免疫、炎症、神经和微血管过程在CCC的发生和疾病进展中起作用。这里要检验的第二个假设是，到目前为止未知或未经测试的生物标记物将在恰加斯病患者的治疗中有用。通过Sami-trop计划中的其他项目识别新的生物标记物，应该能够根据特定并发症和死亡的发生情况对T-cruzi感染患者进行精细分层，并指导CCC患者的治疗。因此，这项研究的第二个目标是收集血液样本，以建立一个强大的样本库，用于测试在该项目的其他分支中发现的新的生物标记物。这些生物标记物的预后重要性将使用嵌套病例对照设计进行测试。

Chronic Chagas cardiopathy (CCC) is a potentially lethal condition, but the severity of the disease varies widely and accurate stratification of the risk of disease progression and death remains an unsolved challenge. Although complex prognostic scores are available, a simple, low-cost and easy-to-use prognostic model, suitable for the primary care setting, is lacking. The first hypothesis of this project is that a prognostic algorithm based on simple ECG measurements in conjunction with clinical information and Brain Natriuretic Peptide (BNP) levels can be developed that will accurately predict the risk of disease progression and death in CCC patients and be useful in clinical practice. The goal is therefore to develop and test a simple predictive algorithm for determining the prognosis of patients with CCC. To accomplish this goal, a large cohort of infected patients will be established based on the Telehealth Program designed to support primary care in Minas Gerais. We will enroll 2,000 CCC patients into this cohort study and follow them for at least two years, in order to develop and validate this simple prognostic algorithm. However we recognize that CCC has a complex physiopathology and many immunological, inflammatory, neural and microvascular processes have a role in development of CCC and progression of disease. The second hypothesis to be tested here is that hitherto unknown or untested biomarkers will be useful in the management of Chagas disease patients. The identification of new biomarkers through the other projects in the SAMI-Trop program should enable refined stratification of T cruzi infected patients with respect to occurrence of specific complications and death and in the guidance of treatment of CCC patients. Consequently, the second goal of this study is to collect blood specimens to establish a robust sample repository for testing of new biomarkers detected in the other branches of this project. The prognostic importance of these biomarkers will be tested using a nested case-control design