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

Chagas Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453700
• Other study ID #: 06H-561004
• Status: Completed
• Start date: January 2007
• Est. completion date: December 2010

Study information

• Verified date: March 2007
• Source: Olive View-UCLA Education & Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: December 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chagas Disease

Intervention

Procedure:
• Trypanosoma cruzi serology

Locations

Country	Name	City	State
United States	OV-UCLA Medical Center	Sylmar	California

Sponsors (2)

Lead Sponsor	Collaborator
Olive View-UCLA Education & Research Institute	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of positive trypanosoma cruzi serologies		At enrollment