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

Endothelial Dysfunction Clinical Trial

Official title:

Investigation of Systemic Microvascular Flow and Reactivity in Patients Presenting in the Acute Phase of Coronavirus Disease-19.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04406545
• Other study ID #: #CAAE 31237220.1.0000.5272
• Status: Completed
• Start date: May 15, 2020
• Est. completion date: January 10, 2022

Study information

• Verified date: January 2022
• Source: National Institute of Cardiology, Laranjeiras, Brazil
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 10, 2022
• Est. primary completion date: January 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Endothelial Dysfunction
• Microvascular Rarefaction

Intervention

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

Locations

Country	Name	City	State
Brazil	National Institute of Cardiology	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiology, Laranjeiras, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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