Microvascular Endothelial Function in a Cohort of Patients With the Cardiac Form of Chronic Chagas Disease.

The present study aims to evaluate the microvascular endothelial function of a single centre cohort of patients with the cardiac form of Chagas disease, and to search for associations with clinical and laboratory variables.

Study Overview

• Status: Completed
• Conditions: Chagas Cardiomyopathy
• Intervention / Treatment: Diagnostic test: skin laser speckle contrast imaging and video-capillaroscopy

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: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 22240-006
    • National Institute of Cardiology, Ministry of Health, Brazil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The present study aims to evaluate the microvascular endothelial function of a single centre cohort of patients presenting with the cardiac form of Chagas disease in the National Institute of Cardiology, Ministry of Health, Rio de Janeiro,, Brazil

Description

Inclusion Criteria:

• patients presenting with Chagas cardiomyopathy

Exclusion Criteria:

• diabetes

Study Plan

How is the study designed?

Number of groups / cohorts

2

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	Diagnostic test: skin laser speckle contrast imaging and 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	Diagnostic test: skin laser speckle contrast imaging and 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	systemic microvascular vasodilation induced by endothelium-dependent agents	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelium-dependent skin capillary density	capillary opening induced by post-occlusive reactive hyperemia	1 hour

Collaborators and Investigators

• Sponsor: National Institute of Cardiology, Laranjeiras, Brazil

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2018
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: April 21, 2018
• First Submitted That Met QC Criteria: May 12, 2018
• First Posted (Actual): May 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: laser speckle contrast imaging; endothelial function, microvascular; capillaroscopy, skin
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Trypanosomiasis; Euglenozoa Infections; Cardiomyopathies; Chagas Cardiomyopathy; Chagas Disease
• Other Study ID Numbers: CHAGASKASALTIBIRIÇÁ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No