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Prognostic Value of Flow-mediated Dilation in Hospitalized COVID-19 Patients

Prognostic Value of Flow-mediated Dilation in Hospitalized Patients With SARS-CoV-2 Infection: an Observational Prospective Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04714125
Enrollment
250
Registered
2021-01-19
Start date
2020-06-19
Completion date
2022-06-01
Last updated
2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, SARS-CoV Infection

Keywords

endothelial function, flow-mediated dilation, vascular function, carotid intima-media thickness

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.

Interventions

None listed

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Composite outcomeUp to hospital discharge, an average of 4 weeksA composite outcome including ICU admission, intubation and all-cause mortality

Secondary

MeasureTime frameDescription
All-cause mortalityUp to hospital discharge, an average of 4 weeksAll-cause mortality rate along the study
ICU admissionUp to hospital discharge, an average of 4 weeksAdmission to the ICU along the study
IntubationUp to hospital discharge, an average of 4 weeksNecessity of intubation along the study
Cardiovascular complicationsUp to hospital discharge, an average of 4 weeksCardiovascular complications, such as arterial, deep venous or pulmonary embolism, acute myocardial infarction, stroke, cardiac arrest, atrial fibrillation and acute kidney injury

Countries

Brazil

Contacts

Primary ContactTiago Peçanha, PhD
tiagopecanha@usp.br11948243542

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026