Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04714125
Recruitment Status : Recruiting
First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated 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 : June 19, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Composite outcome [ Time Frame: Up to hospital discharge, an average of 4 weeks ]
    A composite outcome including ICU admission, intubation and all-cause mortality


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: Up to hospital discharge, an average of 4 weeks ]
    All-cause mortality rate along the study

  2. ICU admission [ Time Frame: Up to hospital discharge, an average of 4 weeks ]
    Admission to the ICU along the study

  3. Intubation [ Time Frame: Up to hospital discharge, an average of 4 weeks ]
    Necessity of intubation along the study

  4. Cardiovascular complications [ Time Frame: 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04714125


Contacts
Layout table for location contacts
Contact: Tiago Peçanha, PhD 11948243542 tiagopecanha@usp.br

Locations
Layout table for location information
Brazil
Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP Recruiting
Sao Paulo, Brazil, 05403-010
Contact: Tiago Peçanha, PhD    5511948243542    tiagopecanha@usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT04714125    
Other Study ID Numbers: FMDCOVID
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sao Paulo General Hospital:
endothelial function
flow-mediated dilation
vascular function
carotid intima-media thickness
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
COVID-19
Severe Acute Respiratory Syndrome
Dilatation, Pathologic
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathological Conditions, Anatomical