Clinical trial NCT04714125: Prognostic Value of Flow-mediated Dilation in Hospitalized COVID-19 Patients
Official title: Prognostic Value of Flow-mediated Dilation in Hospitalized Patients With SARS-CoV-2 Infection: an Observational Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
SARS-CoV Infection
Keywords: endothelial function
flow-mediated dilation
vascular function
carotid intima-media thickness
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female adults with SARS-CoV-2 and recently admitted (≤ 72 hours) to the General Hospital of the Faculty of Medicine of the University of Sao Paulo.

Brief summary: This study will evaluate the associations between vascular parameters and clinical outcomes in patients hospitalized with COVID-19.

The vascular function and structure of individuals with COVID-19 admitted to the General Hospital of the University of Sao Paulo will be assessed in the first 72 hours of hospitalization. Then, participants will be followed up until hospital discharge/death.

Logistical regressions will be run to evaluate if vascular function/structure can predict ICU admissions, intubation, thrombosis or death.

Detailed description: This is a prospective cohort study conducted at the General Hospital of the University of São Paulo Medical School (HCFMUSP). Male and female participants with SARS-CoV-2 and recently admitted to the hospital (≤ 72 hours) will be recruited at the emergency department and outpatient clinics at the HCFMUSP. Immediately upon recruitment, participants will perform the assessment of flow mediated dilation of the brachial artery and the assessment of carotid intima-media thickness. Subsequently, they will be followed during the entire period of hospitalization.

The present study will employ as primary endpoint a composite of ICU admission, intubation or mortality during the period of hospitalization. Cardiovascular complications, such as arterial (AE), deep venous (DVP) or pulmonary embolism (PE) , acute myocardial infarction (AMI), stroke, cardiac arrest, atrial fibrillation and acute kidney injury will be considered secondary endpoints.

The association between the vascular parameters and clinical outcomes will be examined by a multivariate logistic regression.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with SARS-CoV-2
* Recently admitted to the hospital (≤ 72 hours)
* Not yet proceeded to ICU care

Exclusion Criteria:

* Patients transferred from other hospitals
* Participants in delirium state
* Participants with a recent history of endotracheal intubation

Primary outcomes:
measure: Composite outcome
timeFrame: Up to hospital discharge, an average of 4 weeks
Secondary outcomes:
measure: All-cause mortality
timeFrame: Up to hospital discharge, an average of 4 weeks
measure: ICU admission
timeFrame: Up to hospital discharge, an average of 4 weeks
measure: Intubation
timeFrame: Up to hospital discharge, an average of 4 weeks
measure: Cardiovascular complications
timeFrame: Up to hospital discharge, an average of 4 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP
Study officials:
References: