NCT04498299

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

August 4, 2020

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

July 31, 2020

Last Update Submit

July 31, 2020

Conditions

Keywords

Echocardiography, StressCOVID-19Pulmonary Hypertension

Outcome Measures

Primary Outcomes (27)

  • • 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

Interventions

echocardiogram 2DDIAGNOSTIC_TEST

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.

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients after the resolution of acute COVID-19 illness

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Beneficencia Española de Puebla

Puebla City, 72090, Mexico

RECRUITING

MeSH Terms

Conditions

COVID-19Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR INVESTIGATOR
PI Title
cardiovascular critical care unit director

Study Record Dates

First Submitted

July 31, 2020

First Posted

August 4, 2020

Study Start

September 1, 2020

Primary Completion

October 1, 2020

Study Completion

November 30, 2020

Last Updated

August 4, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations