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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00453700
First received: March 28, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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 Intervention
Chagas Disease
Procedure: Trypanosoma cruzi serology

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Prevalence of Chagas Disease in Immigrant Patients With Conduction Abnormalities on Electrocardiogram

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Prevalence of positive trypanosoma cruzi serologies

Estimated Enrollment: 300
Study Start Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453700

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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00453700     History of Changes
Other Study ID Numbers: 06H-561004
Study First Received: March 28, 2007
Last Updated: March 28, 2007
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 20, 2014