Clinical Trial: MicroRNAs as Biomarkers in Patients With Chagas Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Validation of MicroRNAs as Biomarkers for Determining Patients Prognosis With Chagas Disease
Brief Summary: The purpose of this study is to analyze the efficacy of MicroRNAs as biomarkers on the Chagas Disease prognosis. This analysis will be done through the correlation between the plasmatic levels of this molecule with functional and laboratory tests.
Detailed Summary:
The patients included in the study must at first sign the written consent. They shall be accompanied in the specialized outpatient clinics for Chagas disease - Hospital São Rafael - Centro de Biotecnologia e Terapia Celular. They will be submitted to several tests, including:
- Collection of Blood samples for biochemical analysis;
- Electrocardiogram;
- Holter Electrocardiogram;
- Echocardiogram;
- Treadmill Test;
- X-Ray Imaging;
- Magnetic Resonance Imaging;
- Evaluation of the quality of life through the application of questionnaires (SF 36 and the Minnesota Living With Heart Failure Questionnaire).
Sponsor: Hospital Sao Rafael
Current Primary Outcome: Correlation of plasmatic levels of MicroRNAs with the percentage of heart fibrosis [ Time Frame: One year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Correlation of plasmatic levels of MicroRNAs with the functional cardiovascular capacity [ Time Frame: One year ]Mensuration of the functional capacity with treadmill test.
- Correlation of plasmatic levels of MicroRNAs with the left ventricular function [ Time Frame: One year ]Mensuration of the left ventricular function with echocardiogram and magnetic resonance imaging
- Correlation of plasmatic levels of MicroRNAs with the serum levels of Pro-BNP. [ Time Frame: One year ]
- Correlation of plasmatic levels of MicroRNAs with the serum levels of TNF-alpha [ Time Frame: One year ]
- Correlation of plasmatic levels of MicroRNAs with the serum levels of IFN-gamma. [ Time Frame: One year ]
Original Secondary Outcome: Same as current
Information By: Hospital Sao Rafael
Dates:
Date Received: April 23, 2013
Date Started: January 2011
Date Completion:
Last Updated: February 19, 2015
Last Verified: February 2015