NCT03524768

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 20, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

April 21, 2018

Last Update Submit

August 19, 2020

Conditions

Keywords

endothelial function, microvascularlaser speckle contrast imagingcapillaroscopy, skin

Outcome Measures

Primary Outcomes (1)

  • Endothelium-dependent skin microvascular function

    systemic microvascular vasodilation induced by endothelium-dependent agents

    2 hours

Secondary Outcomes (1)

  • Endothelium-dependent skin capillary density

    1 hour

Study Arms (2)

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

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

Interventions

Evaluation of endothelial-dependent microvascular reactivity and capillary recruitment

control grouppatients presenting with Chagas cardiomyopathy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • patients presenting with Chagas cardiomyopathy

You may not qualify if:

  • diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cardiology, Ministry of Health, Brazil

Rio de Janeiro, 22240-006, Brazil

Location

MeSH Terms

Conditions

Chagas Cardiomyopathy

Condition Hierarchy (Ancestors)

Chagas DiseaseTrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsVector Borne DiseasesCardiomyopathiesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher, MD, PhD

Study Record Dates

First Submitted

April 21, 2018

First Posted

May 15, 2018

Study Start

August 20, 2018

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

August 20, 2020

Record last verified: 2020-08

Locations