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

NCT ID: NCT04714125

Last Updated: 2021-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-19

Study Completion Date

2022-06-01

Brief Summary

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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

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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.

Conditions

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Covid19 SARS-CoV Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with COVID-19

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Tiago Peçanha, PhD

Role: CONTACT

11948243542

Facility Contacts

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Tiago Peçanha, PhD

Role: primary

5511948243542

Other Identifiers

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FMDCOVID

Identifier Type: -

Identifier Source: org_study_id

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