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.
1 other identifier
observational
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2020
CompletedFirst Submitted
Initial submission to the registry
May 23, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2022
CompletedJanuary 27, 2022
January 1, 2022
1.7 years
May 23, 2020
January 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (3)
healthy volunteers
skin laser Doppler perfusion monitoring before and after local thermal hyperemia
cardiovascular disease and COVID-19 infection
skin laser Doppler perfusion monitoring before and after local thermal hyperemia
cardiovascular disease without COVID-19 infection
skin laser Doppler perfusion monitoring before and after local thermal hyperemia
Interventions
evaluation of skin microvascular flow and reactivity using laser Doppler perfusion monitoring
Eligibility Criteria
\- We will include adult patients will with SARS-CoV-2 positive RT-PCR, admitted to the hospital in a ward or intensive care unit.
You may not qualify if:
- Presence of non-COVID infection with systemic and microbiologically documented repercussions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Cardiology
Rio de Janeiro, 21040-360, Brazil
Biospecimen
ultra frozen plasma samples will be stocked for the evaluation of inflammatory anti-inflammatory cytokines
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Researcher
Study Record Dates
First Submitted
May 23, 2020
First Posted
May 28, 2020
Study Start
May 15, 2020
Primary Completion
January 10, 2022
Study Completion
January 10, 2022
Last Updated
January 27, 2022
Record last verified: 2022-01