Chagas DiseaseNCT00453700
Prevalence of Chagas Disease in Immigrant Patients With Conduction Abnormalities on Electrocardiogram
An observational study of Chagas Disease, run by Olive View-UCLA Education & Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chagas Disease
- What is being tested?
- Trypanosoma cruzi serology
- Type of treatment
- Surgery or procedure
- How many people
- 327 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Ejection fraction <40%
- Symptomatic heart failure
- Documented coronary artery disease
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Trypanosoma cruzi serology
- Keywords
- chagas, trypanosoma cruzi
- Medical subject headings
- Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trypanosoma cruzi serologyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| serological testing | In Latin American immigrants diagnosed with nonischemic cardiomyopathy in Los Angeles, serological testing for Trypanosoma cruzi was performed at enrollment. Receives: Procedure: Trypanosoma cruzi serology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of positive trypanosoma cruzi serologies
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionApr 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chagas DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olive View-UCLA Education & Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Sheba Meymandi, University of California, Los Angeles
- Investigators
- Sheba K Meymandi, M.D., Principal investigator, OV-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453700
- Sponsor's protocol ID
- 06H-561004
- Status last verified
- Mar 2007
- First submitted
- 28 Mar 2007
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Chagas Disease in Immigrant Patients With Conduction Abnormalities on Electrocardiogram
- ClinicalTrials.gov ID
- NCT00453700
- Acronym / sponsor ID
- 06H-561004
- Conditions
- Chagas Disease
- Keywords
- chagas, trypanosoma cruzi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Olive View-UCLA Education & Research InstituteUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Jan 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| serological testing | – | Procedure: Trypanosoma cruzi serologyIn Latin American immigrants diagnosed with nonischemic cardiomyopathy in Los Angeles, serological testing for Trypanosoma cruzi was performed at enrollment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- One of the following EKG abnormalities:
- 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.
Key exclusion criteria (3 listed)
- Ejection fraction <40%
- Symptomatic heart failure
- Documented coronary artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trypanosoma cruzi serology | Procedure or surgery | serological testing |
Primary outcome
Prevalence of positive trypanosoma cruzi serologies
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheba K Meymandi, M.D. principal investigator
OV-UCLA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chagas Disease, run by Olive View-UCLA Education & Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of positive trypanosoma cruzi serologies (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.