- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03524768
Microvascular Endothelial Function in a Cohort of Patients With the Cardiac Form of Chronic Chagas Disease.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chagas disease is an endemic anthropozoonosis in South America, caused by the protozoaTrypamosoma cruzi. Between 15 and 17 million people are estimated to be infected by the parasite in South America. During the chronic phase, 30 to 40% of patients develop the cardiac or intestinal forms of the disease. The myocardial involvement is divided in two subtypes, according to the presence or absence of systolic ventricular dysfunction. The first type is characterized by heart failure symptoms. The second is acknowledged by the development of various degrees of atrioventricular blockade and by tachyarrhythmias.
Microcirculation function is recognized as a fundamental aspect in the pathophysiology of cardiovascular diseases. The identification of endothelial dysfunction by techniques that assess the microvasculature is considered as both a progression and prognostic marker in various conditions, including hypertension, coronary heart disease, and heart failure.
The effects of T. cruzi infection in vascular function were evaluated in previous studies, performed in animals with acute infection. Previous studies in humans observed medium size vessels (brachial artery), in small groups of patients, most without cardiac dysfunction. There are no studies evaluating the microcirculation of patients with the cardiac form of Chagas disease.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Rio de Janeiro, Brazil, 22240-006
- National Institute of Cardiology, Ministry of Health, Brazil
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients presenting with Chagas cardiomyopathy
Exclusion Criteria:
- diabetes
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients presenting with Chagas cardiomyopathy
Evaluation of systemic microvascular reactivity using laser speckle contrast imaging Evaluation of skin capillary density using video-capillaroscopy
|
Evaluation of endothelial-dependent microvascular reactivity and capillary recruitment
|
control group
Evaluation of systemic microvascular reactivity using laser speckle contrast imaging Evaluation of skin capillary density using video-capillaroscopy
|
Evaluation of endothelial-dependent microvascular reactivity and capillary recruitment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endothelium-dependent skin microvascular function
Time Frame: 2 hours
|
systemic microvascular vasodilation induced by endothelium-dependent agents
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endothelium-dependent skin capillary density
Time Frame: 1 hour
|
capillary opening induced by post-occlusive reactive hyperemia
|
1 hour
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHAGASKASALTIBIRIÇÁ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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