Association between Quantitative Result of Chemiluminescence Immunoassay for Detection of Antibodies Against Trypanosoma cruzi and Cardiovascular Mortality in Patients with Chagas Disease

• Grant number: 24/15643-9
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: October 01, 2024
• End date: September 30, 2025
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal Investigator: Henrique Turin Moreira
• Grantee: Pedro Henrique de Souza Pacheco
• Host Institution: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da USP (HCMRP). Secretaria da Saúde (São Paulo - Estado). Ribeirão Preto , SP, Brazil

Abstract

Introduction: Chagas disease, caused by the protozoan Trypanosoma cruzi (T. cruzi), remains a public health challenge, especially in endemic regions of Latin America, including Brazil. Chronic cardiopathy is its most frequent and ominous clinical expression, potentially leading to heart failure, cardiac arrhythmias, thromboembolic events, and sudden death. The variability of its clinical progression necessitates the identification of biomarkers to refine risk stratification, aiming to optimize monitoring and therapeutic strategies for patients with the disease.Objective: To evaluate the association between the chemiluminescent signal intensity of the chemiluminescence immunoassay (CL-ELISA) test against T. cruzi and the risk of cardiovascular death in patients with Chagas disease.Methods: This longitudinal retrospective analysis study will include adult individuals diagnosed with Chagas disease, excluding those with cardiomyopathy due to other causes. The sample selection will be made from patients consecutively attended at the Hospital das Clínicas of the Faculty of Medicine of Ribeirão Preto, University of São Paulo, since the beginning of the CL-ELISA for Chagas disease at the institution. The exposure variable will be the quantitative result of the CL-ELISA. The outcome of interest will be cardiovascular mortality, assessed by medical record analysis and death certificates. Demographic, anthropometric, and clinical variables will be collected for sample characterization and adjustment of predictive models. Survival analysis will include Kaplan-Meier curves, the log-rank test, and Cox proportional hazard models.