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

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: NCT04498299
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Miguel Ayala León, Hospital Beneficencia Espanola de Puebla

Brief Summary:

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.


Condition or disease Intervention/treatment
Echocardiography, Stress COVID-19 Hypertension, Pulmonary Diagnostic Test: echocardiogram 2D

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stress Echocardiography in Patients Recovery From Mild COVID-19 Illness
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: echocardiogram 2D
    The patient is accelerating against a workload that gradually increases at a constant rate during the exercise, images will be obtained by echocardiography. The patient begins with 25 Watts with increments of 25 Watts every 3 minutes, continuing the exercise until significant electrocardiographic changes occur or the patient starts with symptoms.


Primary Outcome Measures :
  1. • LA volume index [ Time Frame: 3 minutes ]
    Left atrium volume index

  2. • LV telediastolic diameter [ Time Frame: 3 minutes ]
    Left ventricle telediastolic diameter

  3. • LV telesystolic diameter [ Time Frame: 3 minutes ]
    Left ventricle telesystolic diameter

  4. • LV posterior wall [ Time Frame: 3 minutes ]
    Left ventricle posterior wall

  5. • RA area [ Time Frame: 3 minutes ]
    Right atrium area

  6. • RV basal dimensión [ Time Frame: 3 minutes ]
    Right ventricle basal dimensión

  7. • RV mid cavity dimension; [ Time Frame: 3 minutes ]
    Right ventricle cavity dimensión

  8. • RV longitudinal dimension [ Time Frame: 3 minutes ]
    Right ventricle longitudinal dimension

  9. • Distal, RV outflow tract dimension at the distal or pulmonic valve level [ Time Frame: 3 minutes ]
    Distal, right ventricle outflow tract dimension at the distal or pulmonic valve level

  10. • Proximal RV outflow tract dimension at the proximal subvalvular level [ Time Frame: 3 minutes ]
    Proximal right ventricle outflow tract dimension at the proximal subvalvular level

  11. • TAPSE [ Time Frame: 3 minutes ]
    • Tricuspid annular plane systolic excursion

  12. • RV free Wall strain [ Time Frame: 3 minutes ]
    Right ventricle free Wall strain

  13. • Inferior cava vein PW Doppler [ Time Frame: 3 minutes ]
    Inferior cava vein PW Doppler

  14. • E wave mitral [ Time Frame: 3 minutes ]
    E wave mitral

  15. • A wave mitral [ Time Frame: 3 minutes ]
    A wave mitral

  16. • E wave /A wave mitral [ Time Frame: 3 minutes ]
    E wave /A wave mitral

  17. • E-wave at mitral annulus [ Time Frame: 3 minutes ]
    E-wave at mitral annulus

  18. • E-wave at mitral annulus / A-wave at the mitral annulus [ Time Frame: 3 minutes ]
    E-wave at mitral annulus / A-wave at the mitral annulus

  19. • E wave/ E-wave at the mitral annulus [ Time Frame: 3 minutes ]
    E wave/ E-wave at the mitral annulus

  20. • E tricuspid (E) [ Time Frame: 3 minutes ]
    E tricuspid (E)

  21. • A tricuspid (A) [ Time Frame: 3 minutes ]
    A triuspid (A)

  22. • E/A [ Time Frame: 3 minutes ]
    E/A

  23. • Systolic pulmonary artery pressure [ Time Frame: 3 minutes ]
    Systolic pulmonary artery pressure

  24. • E-wave at the tricuspid annulus [ Time Frame: 3 minutes ]
    E-wave at the tricuspid annulus

  25. • Mean pulmonary artery pressure [ Time Frame: 3 minutes ]
    Mean pulmonary artery pressure

  26. • Stroke volume [ Time Frame: 3 minutes ]
    Stroke volume

  27. • Cardiac output [ Time Frame: 3 minutes ]
    Cardiac output



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.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients after the resolution of acute COVID-19 illness
Criteria

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

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): NCT04498299


Contacts
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Contact: miguel ayala-leon 5529625396 terapia_intensiva_miguel@hotmail.com

Locations
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Mexico
Hospital Beneficencia Española de Puebla Recruiting
Puebla, Mexico, 72090
Contact: Miguel Ayala León, Cardiolology    5529625396    librocardicoritica.ma@gmail.com   
Principal Investigator: Miguel Ayala-Leon         
Sub-Investigator: Rosa Tzompantzi-Flores         
Sub-Investigator: Consuelo Orihuela Sandoval         
Sub-Investigator: Jaime Hernandez-Montfort         
Sub-Investigator: Victoria Delgado         
Sponsors and Collaborators
Miguel Ayala León
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Responsible Party: Miguel Ayala León, cardiovascular critical care unit director, Hospital Beneficencia Espanola de Puebla
ClinicalTrials.gov Identifier: NCT04498299    
Other Study ID Numbers: Cardiology-004
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Miguel Ayala León, Hospital Beneficencia Espanola de Puebla:
Echocardiography, Stress
COVID-19
Pulmonary Hypertension
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases