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MicroRNAs as Biomarkers in Patients With Chagas Disease

This study is currently recruiting participants.
Verified April 2013 by Hospital Sao Rafael
Sponsor:
Information provided by (Responsible Party):
Milena Botelho Pereira Soares, Hospital Sao Rafael
ClinicalTrials.gov Identifier:
NCT01842880
First received: April 23, 2013
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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.


Condition
Chagas Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Validation of MicroRNAs as Biomarkers for Determining Patients Prognosis With Chagas Disease

Resource links provided by NLM:


Further study details as provided by Hospital Sao Rafael:

Primary Outcome Measures:
  • Correlation of plasmatic levels of MicroRNAs with the percentage of heart fibrosis [ Time Frame: One year ] [ Designated as safety issue: No ]
    Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging


Secondary Outcome Measures:
  • Correlation of plasmatic levels of MicroRNAs with the functional cardiovascular capacity [ Time Frame: One year ] [ Designated as safety issue: No ]
    Mensuration of the functional capacity with treadmill test.

  • Correlation of plasmatic levels of MicroRNAs with the left ventricular function [ Time Frame: One year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Correlation of plasmatic levels of MicroRNAs with the serum levels of TNF-alpha [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Correlation of plasmatic levels of MicroRNAs with the serum levels of IFN-gamma. [ Time Frame: One year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Plasma, Serum, Whole Blood


Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with Chagas disease diagnosis
Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction.

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).
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Tertiary Hospital

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01842880

Contacts
Contact: Milena Botelho Pereira Soares, PhD +557132816455 milenabpsoares@gmail.com

Locations
Brazil
Hospital São Rafael Recruiting
Salvador, Bahia, Brazil, 41253-190
Contact: Milena Soares, PhD    +557132816455    milenabpsoares@gmail.com   
Sponsors and Collaborators
Hospital Sao Rafael
Investigators
Principal Investigator: Milena Botelho Pereira Soares, PhD Hospital São Rafael
Study Director: Ricardo Ribeiro dos Santos, MD Hospital São Rafael
Study Chair: Ticiana Ferreira Larocca, MD Hospital São Rafael
Study Chair: Márcia Maria Noya Rabelo, MD Hospital São Rafael
Study Chair: Luís Cláudio Lemos Correia, MD Hospital São Rafael
Study Chair: Bruno Solano de Freitas Souza, MD Hospital São Rafael
Study Chair: Carolina Thé Macedo, MD Hospital São Rafael
Study Chair: Ana Luiza Dias Angelo, PhD Hospital São Rafael
  More Information

No publications provided

Responsible Party: Milena Botelho Pereira Soares, PhD, Hospital Sao Rafael
ClinicalTrials.gov Identifier: NCT01842880     History of Changes
Other Study ID Numbers: CEP-41-10-2
Study First Received: April 23, 2013
Last Updated: April 25, 2013
Health Authority: Brazil: Ministry of Health

Keywords provided by Hospital Sao Rafael:
MicroRNAs
Chagas disease
Biomarkers

Additional relevant MeSH terms:
Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on April 15, 2014