Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00453700
Recruitment Status : Completed
First Posted : March 29, 2007
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Sheba Meymandi, University of California, Los Angeles

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

Layout table for study information
Study Type : Observational
Actual Enrollment : 327 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Chagas Disease in Immigrant Patients With Conduction Abnormalities on Electrocardiogram
Study Start Date : January 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chagas Disease

Group/Cohort Intervention/treatment
serological testing
In Latin American immigrants diagnosed with nonischemic cardiomyopathy in Los Angeles, serological testing for Trypanosoma cruzi was performed at enrollment.
Procedure: Trypanosoma cruzi serology



Primary Outcome Measures :
  1. Prevalence of positive trypanosoma cruzi serologies [ Time Frame: At enrollment ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All Latin American immigrant patients with newly diagnosed nonischemic cardiomyopathy at one U.S. medical center were asked to participate in this study.
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

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


Locations
Layout table for location information
United States, California
OV-UCLA Medical Center
Sylmar, California, United States, 91342
Sponsors and Collaborators
Olive View-UCLA Education & Research Institute
Centers for Disease Control and Prevention
Investigators
Layout table for investigator information
Principal Investigator: Sheba K Meymandi, M.D. OV-UCLA Medical Center

Layout table for additonal information
Responsible Party: Sheba Meymandi, Principal Investigator, University of California, Los Angeles
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 13, 2019
Last Verified: March 2007
Keywords provided by Sheba Meymandi, University of California, Los Angeles:
chagas
trypanosoma cruzi
Additional relevant MeSH terms:
Layout table for MeSH terms
Chagas Disease
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases