Heart DiseasesNCT00005455
Chagas Disease as an Undiagnosed Type of Cardiomyopathy in the United States
An observational study of Heart Diseases and Myocardial Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
A detailed review was made of data pertinent to the occurrence of chronic Chagas disease in the United States. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Heart Diseases, Myocardial Diseases, Chagas Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 1993to Dec 1993
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
A detailed review was made of data pertinent to the occurrence of chronic Chagas disease in the United States.
Read the detailed description
BACKGROUND:
In Latin America, 16 to 18 million individuals are thought to have Chagas' disease and 90 million are considered to be at risk of infection. In the United States, the occurrence of Chagas' disease is virtually limited to individuals who have resided in Latin America where they acquired the infection, and then migrated to this country.
DESIGN NARRATIVE:
Data on the prevalence of positive serologic reactions for Trypanosoma cruzi (a protozoan causing Chagas cardiomyopathy) serve for calculating that a total of up to 74,000 Latin Americans residing in the United States have the chronic form of chagasic cardiomyopathy. The vast majority of these individuals are either undiagnosed, or misdiagnosed as having idiopathic dilated cardiomyopathy or coronary artery disease. Vector transmission of T. cruzi infection is very unlikely to occur in the United States because of variations in biological behavior of local species of insect vectors and because of changes in human living conditions. Transfusion of blood from infected but asymptomatic individuals is considered the most important mechanism of transmission of this disorder in the United States.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Heart Diseases, Myocardial Diseases, Chagas Disease
- Medical subject headings
- Heart Diseases, Cardiomyopathies, Chagas Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJan 1993
- Study completionDec 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005455
- Sponsor's protocol ID
- 4488
- Other IDs
- Z01HL005264
- Status last verified
- Nov 2001
- First submitted
- 25 May 2000
- Last updated
- 15 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chagas Disease as an Undiagnosed Type of Cardiomyopathy in the United States
- ClinicalTrials.gov ID
- NCT00005455
- Acronym / sponsor ID
- 4488
- Conditions
- Heart Diseases, Myocardial Diseases, Chagas Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jan 1993
- Study completion
- Dec 1993 (actual)
- First posted
- 26 May 2000 (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.
A detailed review was made of data pertinent to the occurrence of chronic Chagas disease in the United States.
Detailed description
BACKGROUND:
In Latin America, 16 to 18 million individuals are thought to have Chagas' disease and 90 million are considered to be at risk of infection. In the United States, the occurrence of Chagas' disease is virtually limited to individuals who have resided in Latin America where they acquired the infection, and then migrated to this country.
DESIGN NARRATIVE:
Data on the prevalence of positive serologic reactions for Trypanosoma cruzi (a protozoan causing Chagas cardiomyopathy) serve for calculating that a total of up to 74,000 Latin Americans residing in the United States have the chronic form of chagasic cardiomyopathy. The vast majority of these individuals are either undiagnosed, or misdiagnosed as having idiopathic dilated cardiomyopathy or coronary artery disease. Vector transmission of T. cruzi infection is very unlikely to occur in the United States because of variations in biological behavior of local species of insect vectors and because of changes in human living conditions. Transfusion of blood from infected but asymptomatic individuals is considered the most important mechanism of transmission of this disorder in the United States.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 15 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and Myocardial Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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 15 Jul 2016.