Prevalence of Chagas Disease in Immigrant Patients With Conduction Abnormalities on Electrocardiogram

NCT ID: NCT00453700

Last Updated: 2019-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

327 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-12-31

Brief Summary

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Chagas disease is endemic to the Americas, infecting between 16-18 million individuals. In immigrant populations in the United States from endemic areas, it is estimated up to 4.9% may be asymptomatic carriers of Trypanosoma cruzi, the organism which causes Chagas disease. Between 10-20% of these patients progress to development of end-stage cardiomyopathy with a high associated morbidity. Following acute disease, patients enter into an indeterminate phase which can last 10-20 years. The earliest sign of cardiac involvement usually is electrocardiogram abnormalities. The most common abnormality is right bundle branch block (RBBB), followed by left anterior fascicular block (LAFB), and left bundle branch block (LBBB). Recent studies have shown that treatment of patients at this stage with antiparasitics may delay the progression of overt cardiomyopathy.

At the University of California, Los Angeles, there is a large population of immigrant patients from countries endemic to Chagas disease. The researchers propose that screening patients with conduction abnormalities on electrocardiogram may be a potentially useful method to identify patients with early cardiac manifestations of Chagas disease. The researchers hope to enroll approximately 300 individuals with RBBB, LAFB or LBBB on electrocardiogram to determine the incidence of Chagas disease in this patient population.

Detailed Description

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Conditions

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Chagas Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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serological testing

In Latin American immigrants diagnosed with nonischemic cardiomyopathy in Los Angeles, serological testing for Trypanosoma cruzi was performed at enrollment.

Trypanosoma cruzi serology

Intervention Type PROCEDURE

Interventions

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Trypanosoma cruzi serology

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* One of the following EKG abnormalities:

* Complete or incomplete right bundle branch block (RBBB)
* Left anterior fascicular block (LAFB)
* Left bundle branch block (LBBB)
* Residence at any point in past in an endemic area (any country in Central or South America or Mexico) for at least 12 months.
* Age \>18 and \<60.

Exclusion Criteria

* Ejection fraction \<40%
* Symptomatic heart failure
* Documented coronary artery disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Olive View-UCLA Education & Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Sheba Meymandi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sheba K Meymandi, M.D.

Role: PRINCIPAL_INVESTIGATOR

OV-UCLA Medical Center

Locations

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OV-UCLA Medical Center

Sylmar, California, United States

Site Status

Countries

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United States

Other Identifiers

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06H-561004

Identifier Type: -

Identifier Source: org_study_id

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