An observational study in Coronavirus Infection, Endothelial Dysfunction and Microvascular Rarefaction, sponsored by National Institute of Cardiology, Laranjeiras, Brazil. Completed at 1 site in Brazil. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-27.
Sponsored by National Institute of Cardiology, Laranjeiras, Brazil · Observational
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.
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.
952 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.
This study's enrollment of 25 is below the median of 300 across 348 observational studies indexed under Coronavirus Infections.
Browse Coronavirus Infections studies →National Institute of Cardiology, Laranjeiras, Brazil is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
- We will include adult patients will with SARS-CoV-2 positive RT-PCR, admitted to the hospital in a ward or intensive care unit.
Exclusion Criteria:
skin laser Doppler perfusion monitoring before and after local thermal hyperemia
Other: evaluation of skin microvascular flow and reactivity
skin laser Doppler perfusion monitoring before and after local thermal hyperemia
Other: evaluation of skin microvascular flow and reactivity
skin laser Doppler perfusion monitoring before and after local thermal hyperemia
evaluation of skin microvascular flow and reactivity using laser Doppler perfusion monitoring
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
Time frame: Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room.
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
Time frame: Microvascular reactivity will be evaluated after a 20-minute rest in the supine position in a temperature-controlled room
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from May 2020 to primary completion in Jan 2022, 19 months.
Of 200 non-industry observational studies under Coronavirus Infections, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 19 months is above that.
Counting every sponsor, half of 218 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institute of Cardiology, Laranjeiras, Brazil