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

Completed

• Conditions: Microvascular Rarefaction; Endothelial Dysfunction; Coronavirus Infection
• Interventions: Other: evaluation of skin microvascular flow and reactivity

• Registration Number: NCT04406545
• Lead Sponsor: National Institute of Cardiology, Laranjeiras, Brazil

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-05-15
• Study First Submitted: 2020-05-23
• Study First Submitted QC: 2020-05-23
• Study First Posted: 2020-05-28
• Status Verified: 2022-01
• Primary Completion: 2022-01-10
• Study Completion: 2022-01-10
• Last Update Submitted: 2022-01-11
• Last Update Posted: 2022-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

• Presence of non-COVID infection with systemic and microbiologically documented repercussions.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cardiovascular disease and COVID-19 infection	evaluation of skin microvascular flow and reactivity	skin laser Doppler perfusion monitoring before and after local thermal hyperemia
healthy volunteers	evaluation of skin microvascular flow and reactivity	skin laser Doppler perfusion monitoring before and after local thermal hyperemia

Primary Outcome Measures

Name	Time	Method
To evaluate, through laser doppler, the presence of changes in systemic microvascular endothelial function in patients in the acute phase of COVID-19.	Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.	skin laser Doppler perfusion monitoring before and after local thermal hyperemia

Secondary Outcome Measures

Name	Time	Method
To evaluate, using laser Doppler perfusion monitoring, the presence of changes in systemic microvascular endothelial function in patients twelve months after COVID-19 recovery.	Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room	Skin laser Doppler perfusion monitoring before and after local thermal hyperemia

Trial Locations

Locations (1)

National Institute of Cardiology; 🇧🇷 Rio de Janeiro, Brazil