Assessment of Speckle Tracking Strain Predictive Value for Myocardial Fibrosis in Chagas Disease

NCT02327052 | Completed Results

• 1 other identifier: PCL01-04
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

One of the most challenging issues of chronic Chagas disease is to provide earlier detection of heart involvement. Two-dimensional speckle tracking (2-D ST) echocardiography, a new imaging modality with useful applications in several cardiac diseases, has been validated for subjects with myocardial infarction against cardiac magnetic resonance (CMR). Here the investigators hypothesize that the longitudinal global strain (LGS) has an incremental value to ejection fraction for predicting myocardial fibrosis in subjects with Chagas disease.

Conditions

Chagas Disease

Keywords

Chagas disease; longitudinal global strain; speckle tracking

Outcome Measures

Primary Outcomes (1)

• Correlation Between Longitudinal Global Strain and the Percentage of Myocardial Fibrosis on Magnetic Resonance

  Longitudinal global strain were assesseb by standard transthoracic echocardiographic examinations were recorded in all subjects using the Vivid 7 digital ultrasound system (GE Vingmed Ultrasound AS, Horten, Norway) and myocardial fibrosis by cardiac magnetic resonance exams were performed on all subjects using the General Electric Sigma HDx 1.5-T system (Fairfield, CT, USA). .

  Both outcome measures will be assessed at one month of follow up.

Study Arms (1)

Chagas disease

The study comprised 58 subjects with Chagas disease, confirmed by two positive serologic tests.

Other: No intervention was performed.

Interventions

No intervention was performed. OTHER

No intervention was performed.

Chagas disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects in the Chagas disease outpatient clinics at our institution from January 2011 to December 2013 were invited to participate in this study.

You may qualify if:

• Chagas disease, established based on microbiological confirmation by two positive serologic tests (indirect hemagglutination and indirect immunofluorescence)
• Between 18 and 70 years of age.

You may not qualify if:

• Previous myocardial infarction or history of coronary artery disease
• Primary valve disease
• Dialysis treatment of terminal renal failure
• Liver disease in activity
• Hematologic, neoplastic or bone diseases
• And MRI contraindications.

Sponsors & Collaborators

• Hospital Sao Rafael: lead

Study Sites (1)

Hospital São Rafael

Salvador, Estado de Bahia, 41253-190, Brazil

Location

MeSH Terms

Conditions

Chagas Disease

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Results Point of Contact

• Title: Dr. Milena Botelho Pereira Soares
• Organization: Hospital São Rafael

milenabpsoares@gmail.com

+557132816455

Study Officials

• Milena Soares, PhD

  Hospital São Rafael

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assessment of Speckle Tracking Strain Predictive Value for Myocardial Fibrosis in Subjects with Chagas Disease

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 30, 2014
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 24, 2021
• Results First Posted: March 24, 2021

Record last verified: 2021-03

Locations

BR (1)