MicroRNAs as Biomarkers in Patients With Chagas Disease

February 19, 2015 updated by: Milena Botelho Pereira Soares, Hospital Sao Rafael

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 41253-190
        • Hospital Sao Rafael

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Tertiary Hospital

Description

Inclusion Criteria:

  • Chagas disease diagnosis confirmed by 2 different serologies
  • Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction.

Exclusion Criteria:

  • Significant valve disease defined as aortic stenosis with a gradient of VE/Ao > 50 mmHg
  • Mitral stenosis with a valve area inferior than 1,5 cm2
  • Severe or moderate aortic and/or mitral regurgitation
  • Chronic use of immunosuppressive agents
  • Dialysis treatment of terminal renal failure
  • Fever on the last 48 hours or evidence of systemic infection in activity according to the definition of sepsis of the ACCP/SCCM (American College os Chest Physicians/Society of Critical Care Medicine)
  • Current abusive use of alcohol or illicit drugs (Based on the DSM IV)
  • Any other comorbidities that impact patient's survival within the next 2 years
  • Liver disease in activity
  • Continuous use of steroids as treatment for COPD
  • Hematologic, neoplastic or bone diseases
  • Homeostasis disturbances
  • Inflammatory diseases or chronic infectious diseases

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with Chagas disease diagnosis
Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of plasmatic levels of MicroRNAs with the percentage of heart fibrosis
Time Frame: One year
Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of plasmatic levels of MicroRNAs with the functional cardiovascular capacity
Time Frame: One year
Mensuration of the functional capacity with treadmill test.
One year
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
One year
Correlation of plasmatic levels of MicroRNAs with the serum levels of Pro-BNP.
Time Frame: One year
One year
Correlation of plasmatic levels of MicroRNAs with the serum levels of TNF-alpha
Time Frame: One year
One year
Correlation of plasmatic levels of MicroRNAs with the serum levels of IFN-gamma.
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sao Rafael

Investigators

  • Principal Investigator: Milena Botelho Pereira Soares, PhD, Hospital Sao Rafael
  • Study Chair: Carolina Thé Macedo, MD, Hospital Sao Rafael
  • Study Director: Ricardo Ribeiro dos Santos, MD, Hospital Sao Rafael
  • Study Chair: Ticiana Ferreira Larocca, MD, Hospital Sao Rafael
  • Study Chair: Márcia Maria Noya Rabelo, MD, Hospital Sao Rafael
  • Study Chair: Luís Cláudio Lemos Correia, MD, Hospital Sao Rafael
  • Study Chair: Bruno Solano de Freitas Souza, MD, Hospital Sao Rafael
  • Study Chair: Ana Luiza Dias Angelo, PhD, Hospital Sao Rafael

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

April 25, 2013

First Posted (Estimate)

April 30, 2013

Study Record Updates

Last Update Posted (Estimate)

February 20, 2015

Last Update Submitted That Met QC Criteria

February 19, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP-41-10-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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