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

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ClinicalTrials.gov Identifier: NCT00453700
Recruitment Status : Unknown
Verified March 2007 by University of California, Los Angeles.
Recruitment status was:  Recruiting
First Posted : March 29, 2007
Last Update Posted : March 29, 2007
Information provided by:

Study Description
Brief Summary:

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.

Condition or disease Intervention/treatment
Chagas Disease Procedure: Trypanosoma cruzi serology

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Prevalence of Chagas Disease in Immigrant Patients With Conduction Abnormalities on Electrocardiogram
Study Start Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chagas Disease
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Prevalence of positive trypanosoma cruzi serologies

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453700

Contact: Sheba K Meymandi, M.D. 818-364-4289 smeymandi@ladhs.org
Contact: Mahmoud I Traina, M.D. 818-364-4287 mitraina@gmail.com

United States, California
OV-UCLA Medical Center Recruiting
Sylmar, California, United States, 91342
Sponsors and Collaborators
University of California, Los Angeles
Centers for Disease Control and Prevention
Principal Investigator: Sheba K Meymandi, M.D. OV-UCLA Medical Center
More Information

ClinicalTrials.gov Identifier: NCT00453700     History of Changes
Other Study ID Numbers: 06H-561004
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: March 29, 2007
Last Verified: March 2007

Keywords provided by University of California, Los Angeles:
trypanosoma cruzi

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