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

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04714125

Collaborator

(none)

250

Enrollment

Location

23.4

Anticipated Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 SARS-CoV Infection

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 19, 2020

Anticipated Primary Completion Date :

Feb 1, 2021

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with COVID-19 Patients hospitalized with COVID-19 from the General Hospital of the University of Sao Paulo, Brazil.

Outcome Measures

Primary Outcome Measures

Composite outcome [Up to hospital discharge, an average of 4 weeks]
A composite outcome including ICU admission, intubation and all-cause mortality

Secondary Outcome Measures

All-cause mortality [Up to hospital discharge, an average of 4 weeks]
All-cause mortality rate along the study
ICU admission [Up to hospital discharge, an average of 4 weeks]
Admission to the ICU along the study
Intubation [Up to hospital discharge, an average of 4 weeks]
Necessity of intubation along the study
Cardiovascular complications [Up to hospital discharge, an average of 4 weeks]
Cardiovascular complications, such as arterial, deep venous or pulmonary embolism, acute myocardial infarction, stroke, cardiac arrest, atrial fibrillation and acute kidney injury