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

July 31, 2020 updated by: Miguel Ayala León

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Mexico
      • Puebla, Mexico, 72090
        • Recruiting
        • Hospital Beneficencia Española de Puebla
        • Contact:
        • Principal Investigator:
          • Miguel Ayala-Leon
        • Sub-Investigator:
          • Rosa Tzompantzi-Flores
        • Sub-Investigator:
          • Jaime Hernandez-Montfort
        • Sub-Investigator:
          • Victoria Delgado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
• LA volume index
Time Frame: 3 minutes
Left atrium volume index
3 minutes
• LV telediastolic diameter
Time Frame: 3 minutes
Left ventricle telediastolic diameter
3 minutes
• LV telesystolic diameter
Time Frame: 3 minutes
Left ventricle telesystolic diameter
3 minutes
• LV posterior wall
Time Frame: 3 minutes
Left ventricle posterior wall
3 minutes
• RA area
Time Frame: 3 minutes
Right atrium area
3 minutes
• RV basal dimensión
Time Frame: 3 minutes
Right ventricle basal dimensión
3 minutes
• RV mid cavity dimension;
Time Frame: 3 minutes
Right ventricle cavity dimensión
3 minutes
• RV longitudinal dimension
Time Frame: 3 minutes
Right ventricle longitudinal dimension
3 minutes
• 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
3 minutes
• 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
3 minutes
• TAPSE
Time Frame: 3 minutes
• Tricuspid annular plane systolic excursion
3 minutes
• RV free Wall strain
Time Frame: 3 minutes
Right ventricle free Wall strain
3 minutes
• Inferior cava vein PW Doppler
Time Frame: 3 minutes
Inferior cava vein PW Doppler
3 minutes
• E wave mitral
Time Frame: 3 minutes
E wave mitral
3 minutes
• A wave mitral
Time Frame: 3 minutes
A wave mitral
3 minutes
• E wave /A wave mitral
Time Frame: 3 minutes
E wave /A wave mitral
3 minutes
• E-wave at mitral annulus
Time Frame: 3 minutes
E-wave at mitral annulus
3 minutes
• 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
3 minutes
• E wave/ E-wave at the mitral annulus
Time Frame: 3 minutes
E wave/ E-wave at the mitral annulus
3 minutes
• E tricuspid (E)
Time Frame: 3 minutes
E tricuspid (E)
3 minutes
• A tricuspid (A)
Time Frame: 3 minutes
A triuspid (A)
3 minutes
• E/A
Time Frame: 3 minutes
E/A
3 minutes
• Systolic pulmonary artery pressure
Time Frame: 3 minutes
Systolic pulmonary artery pressure
3 minutes
• E-wave at the tricuspid annulus
Time Frame: 3 minutes
E-wave at the tricuspid annulus
3 minutes
• Mean pulmonary artery pressure
Time Frame: 3 minutes
Mean pulmonary artery pressure
3 minutes
• Stroke volume
Time Frame: 3 minutes
Stroke volume
3 minutes
• Cardiac output
Time Frame: 3 minutes
Cardiac output
3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Miguel Ayala León

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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