Completed

Validation of MicroRNAs as Biomarkers for Determining Patients Prognosis With Chagas Disease

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
DNA Samples
Who is being recruted

Vector Borne Diseases+4

+ Infections

+ Parasitic Diseases

From 18 to 70 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: January 2011
See protocol details

Summary

Principal SponsorHospital Sao Rafael
Last updated: February 20, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2011

Actual date on which the first participant was enrolled.

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).

NCT01842880
Principal SponsorHospital Sao Rafael
Last updated: February 20, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Vector Borne DiseasesInfectionsParasitic DiseasesProtozoan InfectionsTrypanosomiasisEuglenozoa InfectionsChagas Disease

Criteria

2 inclusion criteria required to participate
Chagas disease diagnosis confirmed by 2 different serologies
Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction
13 exclusion criteria prevent from participating
Any other comorbidities that impact patient's survival within the next 2 years
Chronic use of immunosuppressive agents
Continuous use of steroids as treatment for COPD
Current abusive use of alcohol or illicit drugs (Based on the DSM IV)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hospital São Rafael

Salvador, BrazilOpen Hospital São Rafael in Google Maps
CompletedOne Study Center