Stress Echocardiography in Patients Recovery From Mild COVID-19 Illness (ECHO-vid)

With the appearance of the new SARS-COV2 virus, additional challenges are being imposed on the medical community after the resolution of acute COVID-19 illness, resulting in specific pathophysiologic mechanisms that while acutely damage the lung parenchyma might chronically impact the cardiopulmonary system.

This study aims to investigate changes after mild COVID-19 illness in echocardiographic indices at rest and stress.

Study Overview

• Status: Unknown
• Conditions: COVID-19; Hypertension, Pulmonary; Echocardiography, Stress
• Intervention / Treatment: Diagnostic test: echocardiogram 2D

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: miguel ayala-leon; Phone Number: 5529625396; Email: terapia_intensiva_miguel@hotmail.com

Study Locations

• Mexico
  • Puebla, Mexico, 72090
    • Recruiting
    • Hospital Beneficencia Española de Puebla
    • Contact: Miguel Ayala León, Cardiolology; Phone Number: 5529625396; Email: librocardicoritica.ma@gmail.com
    • Principal Investigator: Miguel Ayala-Leon
    • Sub-Investigator: Rosa Tzompantzi-Flores
    • Sub-Investigator: Jaime Hernandez-Montfort
    • Sub-Investigator: Victoria Delgado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients after the resolution of acute COVID-19 illness

Description

Inclusion Criteria:

• Having suffered mild COVID-19 illness
• PCR test negative after COVID-19 illness
• Men or women
• Age ≥18 years and < 45.
• No history of other cardiovascular or lung disease.
• No cardiovascular risk factors, that is, arterial systemic hypertension, smoking, diabetes, dyslipidemia
• No ongoing or previous cardio or vasoactive treatment
• Able to use the semi-supine exercise bicycle
• Able to give informed consent

Exclusion Criteria:

• Poor acoustic window.
• Tricuspid regurgitation more than mild
• Professional sports activity
• Pregnancy
• Obesity (body mass index [BMI], ≥30 kg/m2).
• Inability to provide consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• LA volume index	Left atrium volume index	3 minutes
• LV telediastolic diameter	Left ventricle telediastolic diameter	3 minutes
• LV telesystolic diameter	Left ventricle telesystolic diameter	3 minutes
• LV posterior wall	Left ventricle posterior wall	3 minutes
• RA area	Right atrium area	3 minutes
• RV basal dimensión	Right ventricle basal dimensión	3 minutes
• RV mid cavity dimension;	Right ventricle cavity dimensión	3 minutes
• RV longitudinal dimension	Right ventricle longitudinal dimension	3 minutes
• Distal, RV outflow tract dimension at the distal or pulmonic valve level	Distal, right ventricle outflow tract dimension at the distal or pulmonic valve level	3 minutes
• Proximal RV outflow tract dimension at the proximal subvalvular level	Proximal right ventricle outflow tract dimension at the proximal subvalvular level	3 minutes
• TAPSE	• Tricuspid annular plane systolic excursion	3 minutes
• RV free Wall strain	Right ventricle free Wall strain	3 minutes
• Inferior cava vein PW Doppler	Inferior cava vein PW Doppler	3 minutes
• E wave mitral	E wave mitral	3 minutes
• A wave mitral	A wave mitral	3 minutes
• E wave /A wave mitral	E wave /A wave mitral	3 minutes
• E-wave at mitral annulus	E-wave at mitral annulus	3 minutes
• E-wave at mitral annulus / A-wave at the mitral annulus	E-wave at mitral annulus / A-wave at the mitral annulus	3 minutes
• E wave/ E-wave at the mitral annulus	E wave/ E-wave at the mitral annulus	3 minutes
• E tricuspid (E)	E tricuspid (E)	3 minutes
• A tricuspid (A)	A triuspid (A)	3 minutes
• E/A	E/A	3 minutes
• Systolic pulmonary artery pressure	Systolic pulmonary artery pressure	3 minutes
• E-wave at the tricuspid annulus	E-wave at the tricuspid annulus	3 minutes
• Mean pulmonary artery pressure	Mean pulmonary artery pressure	3 minutes
• Stroke volume	Stroke volume	3 minutes
• Cardiac output	Cardiac output	3 minutes

Collaborators and Investigators

• Sponsor: Miguel Ayala León

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 4, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; Pulmonary Hypertension; Echocardiography, Stress
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: Cardiology-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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