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

Investigation of Systemic Microvascular Flow and Reactivity in Patients Presenting in the Acute Phase of Coronavirus Disease-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 looking for to evaluate associations between the presence of endothelial dysfunction and demographic, clinical and laboratory variables.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infection; Endothelial Dysfunction; Microvascular Rarefaction
• Intervention / Treatment: Other: evaluation of skin microvascular flow and reactivity

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 Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 21040-360
    • National Institute of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

- We will include adult patients will with SARS-CoV-2 positive RT-PCR, admitted to the hospital in a ward or intensive care unit.

Description

• Age> 18 years admitted to the hospital
• SARS-CoV-2 positive real-time PCR molecular test

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy volunteers; skin laser Doppler perfusion monitoring before and after local thermal hyperemia	Other: evaluation of skin microvascular flow and reactivity; 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	Other: evaluation of skin microvascular flow and reactivity; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Institute of Cardiology, Laranjeiras, Brazil

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2020
• Primary Completion (ACTUAL): January 10, 2022
• Study Completion (ACTUAL): January 10, 2022

Study Registration Dates

• First Submitted: May 23, 2020
• First Submitted That Met QC Criteria: May 23, 2020
• First Posted (ACTUAL): May 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pathological Conditions, Anatomical; Coronavirus Infections; Microvascular Rarefaction
• Other Study ID Numbers: #CAAE 31237220.1.0000.5272

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