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

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ClinicalTrials.gov Identifier: NCT04406545
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Eduardo Tibirica, MD, PhD, 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.

Condition or disease Intervention/treatment
Coronavirus Infection Endothelial Dysfunction Microvascular Rarefaction 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.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of Systemic Microvascular Flow and Reactivity in Patients Presenting in the Acute Phase of Coronavirus Disease-19.
Actual Study Start Date : May 15, 2020
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. To evaluate, through laser doppler, the presence of changes in systemic microvascular endothelial function in patients in the acute phase of COVID-19. [ Time Frame: 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


Biospecimen Retention:   Samples Without DNA
ultra frozen plasma samples will be stocked for the evaluation of inflammatory anti-inflammatory cytokines


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406545


Contacts
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Contact: Eduardo Tibirica, MD, PhD +55-21-99914-6075 etibi@uol.com.br

Locations
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Brazil
National Institute of Cardiology Recruiting
Rio de Janeiro, Brazil, 21040-360
Contact: Eduardo Tibirica    2125921265    eitib@uol.com.br   
Sponsors and Collaborators
National Institute of Cardiology, Laranjeiras, Brazil
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Responsible Party: Eduardo Tibirica, MD, PhD, Senior Researcher, National Institute of Cardiology, Laranjeiras, Brazil
ClinicalTrials.gov Identifier: NCT04406545    
Other Study ID Numbers: #CAAE 31237220.1.0000.5272
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Microvascular Rarefaction
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Pathological Conditions, Anatomical