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

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.

Study Overview

• Status: Unknown
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05403-010
    • Recruiting
    • Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP
    • Contact: Tiago Peçanha, PhD; Phone Number: 5511948243542; Email: tiagopecanha@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with COVID-19; Patients hospitalized with COVID-19 from the General Hospital of the University of Sao Paulo, Brazil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite outcome	A composite outcome including ICU admission, intubation and all-cause mortality	Up to hospital discharge, an average of 4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: vascular function; flow-mediated dilation; endothelial function; carotid intima-media thickness
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Pathological Conditions, Anatomical; Severe Acute Respiratory Syndrome; COVID-19; Infections; Dilatation, Pathologic
• Other Study ID Numbers: FMDCOVID

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No