NCT01842880

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 20, 2015

Status Verified

February 1, 2015

Enrollment Period

2.4 years

First QC Date

April 23, 2013

Last Update Submit

February 19, 2015

Conditions

Chagas Disease

Keywords

MicroRNAsChagas diseaseBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Correlation of plasmatic levels of MicroRNAs with the percentage of heart fibrosis

    Mensuration of heart fibrosis percentage with Magnetic Resonance Imaging

    One year

Secondary Outcomes (5)

  • Correlation of plasmatic levels of MicroRNAs with the functional cardiovascular capacity

    One year

  • Correlation of plasmatic levels of MicroRNAs with the left ventricular function

    One year

  • Correlation of plasmatic levels of MicroRNAs with the serum levels of Pro-BNP.

    One year

  • Correlation of plasmatic levels of MicroRNAs with the serum levels of TNF-alpha

    One year

  • Correlation of plasmatic levels of MicroRNAs with the serum levels of IFN-gamma.

    One year

Study Arms (1)

Patients with Chagas disease diagnosis

Diagnosis of Chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tertiary Hospital

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital São Rafael

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum, Whole Blood

MeSH Terms

Conditions

Chagas Disease

Condition Hierarchy (Ancestors)

TrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne Diseases

Study Officials

  • Milena Botelho Pereira Soares, PhD

    Hospital São Rafael

    PRINCIPAL INVESTIGATOR

  • Ricardo Ribeiro dos Santos, MD

    Hospital São Rafael

    STUDY DIRECTOR

  • 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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 23, 2013

First Posted

April 30, 2013

Study Start

January 1, 2011

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

February 20, 2015

Record last verified: 2015-02

Locations

BR(1)