Microvascular Flow and Reactivity in Patients Presenting in the Acute Phase of COVID-19.

NCT ID: NCT04406545

Last Updated: 2022-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-15

Study Completion Date

2022-01-10

Brief Summary

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Considering that the intensity of systemic microvascular changes in patients in the acute phase of COVID-19 could be related to disease progression and prognosis, the present cross-sectional and observational study aims to investigate the presence of endothelial dysfunction in these patients, also looking for to evaluate associations between the presence of endothelial dysfunction and demographic, clinical and laboratory variables.

Detailed Description

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An association between the presence of previous cardiovascular disease and adverse prognosis has been demonstrated in patients with COVID-19 (coronavirus disease-19), presenting increases of up to 5-10 times in mortality.

As an initial process, the SARS-CoV-2 virus, anchored in the transmembrane angiotensin-converting enzyme 2 (ECA2), penetrates host cells, including endothelial cells, pericytes and macrophages, in addition to type II pneumocytes.

Cellular invasion results in massive release of several pro-inflammatory cytokines ("cytokine storm"), such as IL-1β, IFN-1 and IL-6, by the cells of the immune system. In turn, cytokines increase the process of vascular inflammation and the expression of leukocyte-vascular endothelium adhesion proteins, which results in endothelial activation accompanied by a pro-coagulant and pro-adhesive phenotype - between leukocytes, platelets, red blood cells and vascular endothelium - characteristic of the dysfunctional endothelium in the microcirculation, which results in severe changes in the microvascular flow and, as a result, in tissue perfusion.

It is also worth noting that the patients most vulnerable to the development of complications are those with pre-existing endothelial dysfunction, associated with several risk factors such as male gender and smoking, and comorbidities such as hypertension, diabetes and obesity, all of which are associated with poor prognosis in COVID -19.

Considering that the intensity of systemic microvascular changes in patients in the acute phase of COVID-19 could be related to disease progression and prognosis, the present cross-sectional and observational study aims to investigate the presence of endothelial dysfunction in these patients, also evaluating associations between the presence of endothelial dysfunction and demographic, clinical and laboratory variables.

Conditions

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Coronavirus Infection Endothelial Dysfunction Microvascular Rarefaction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy volunteers

skin laser Doppler perfusion monitoring before and after local thermal hyperemia

evaluation of skin microvascular flow and reactivity

Intervention Type OTHER

evaluation of skin microvascular flow and reactivity using laser Doppler perfusion monitoring

cardiovascular disease and COVID-19 infection

skin laser Doppler perfusion monitoring before and after local thermal hyperemia

evaluation of skin microvascular flow and reactivity

Intervention Type OTHER

evaluation of skin microvascular flow and reactivity using laser Doppler perfusion monitoring

cardiovascular disease without COVID-19 infection

skin laser Doppler perfusion monitoring before and after local thermal hyperemia

No interventions assigned to this group

Interventions

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evaluation of skin microvascular flow and reactivity

evaluation of skin microvascular flow and reactivity using laser Doppler perfusion monitoring

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

* Presence of non-COVID infection with systemic and microbiologically documented repercussions.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Cardiology, Laranjeiras, Brazil

OTHER_GOV

Sponsor Role lead

Responsible Party

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Eduardo Tibirica, MD, PhD

Senior Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Institute of Cardiology

Rio de Janeiro, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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#CAAE 31237220.1.0000.5272

Identifier Type: -

Identifier Source: org_study_id

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