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

Completed

• Conditions: Chagas Disease
• Interventions: Procedure: Trypanosoma cruzi serology

• Registration Number: NCT00453700
• Lead Sponsor: Olive View-UCLA Education & Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Status Verified: 2007-03
• Study First Submitted: 2007-03-28
• Study First Submitted QC: 2007-03-28
• Study First Posted: 2007-03-29
• Primary Completion: 2009-04
• Study Completion: 2010-12
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Prevalence of positive trypanosoma cruzi serologies	At enrollment

Trial Locations

Locations (1)

OV-UCLA Medical Center; 🇺🇸 Sylmar, California, United States