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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04498299
Other study ID # Cardiology-004
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date November 30, 2020

Study information

Verified date July 2020
Source Hospital Beneficencia Espanola de Puebla
Contact miguel ayala-leon
Phone 5529625396
Email terapia_intensiva_miguel@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date November 30, 2020
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Mexico Hospital Beneficencia Española de Puebla Puebla

Sponsors (1)

Lead Sponsor Collaborator
Miguel Ayala León

Country where clinical trial is conducted

Mexico, 

Outcome

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