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

NCT00453700 | Completed

• 1 other identifier: 06H-561004
• Study Type: observational
• Target: 327
• Locations: 1 country
• Sites: 1

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.

Conditions

Chagas Disease

Keywords

chagas; trypanosoma cruzi

Outcome Measures

Primary Outcomes (1)

• Prevalence of positive trypanosoma cruzi serologies

  At enrollment

Study Arms (1)

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

Interventions

Trypanosoma cruzi serology PROCEDURE

serological testing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Ejection fraction \<40%
• Symptomatic heart failure
• Documented coronary artery disease

Sponsors & Collaborators

• Olive View-UCLA Education & Research Institute: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

OV-UCLA Medical Center

Sylmar, California, 91342, United States

Location

MeSH Terms

Conditions

Chagas Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Sheba K Meymandi, M.D.

  OV-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2007
• First Posted: March 29, 2007
• Study Start: January 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: December 1, 2010
• Last Updated: March 13, 2019

Record last verified: 2007-03

Locations

US (1)