Echocardiography, StressECHO-vidNCT04498299
Stress Echocardiography in Patients Recovery From Mild COVID-19 Illness
An observational study of Echocardiography, Stress and COVID-19, run by Miguel Ayala León at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Echocardiography, Stress, COVID-19, Hypertension, Pulmonary
- What is being tested?
- echocardiogram 2D
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2020to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients after the resolution of acute COVID-19 illness
Who may be able to join
- 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
Show all 9Show fewer
- No ongoing or previous cardio or vasoactive treatment
- Able to use the semi-supine exercise bicycle
- Able to give informed consent
Who cannot join
- Poor acoustic window.
- Tricuspid regurgitation more than mild
- Professional sports activity
- Pregnancy
- Obesity (body mass index [BMI], ≥30 kg/m2).
- Inability to provide consent
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Beneficencia Española de Puebla
Puebla City, 72090
Miguel Ayala León, Cardiolology, 5529625396, librocardicoritica.ma@gmail.com
Miguel Ayala-Leon
About this study
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.
- Conditions
- Echocardiography, Stress, COVID-19, Hypertension, Pulmonary
- Being tested
- echocardiogram 2D
- Keywords
- Echocardiography, Stress, COVID-19, Pulmonary Hypertension
- Medical subject headings
- COVID-19, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
• LA volume index
Left atrium volume index
Measured: 3 minutes
• LV telediastolic diameter
Left ventricle telediastolic diameter
Measured: 3 minutes
• LV telesystolic diameter
Left ventricle telesystolic diameter
Measured: 3 minutes
• LV posterior wall
Left ventricle posterior wall
Measured: 3 minutes
• RA area
Right atrium area
Measured: 3 minutes
• RV basal dimensión
Right ventricle basal dimensión
Measured: 3 minutes
• RV mid cavity dimension;
Right ventricle cavity dimensión
Measured: 3 minutes
• RV longitudinal dimension
Right ventricle longitudinal dimension
Measured: 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
Measured: 3 minutes
• Proximal RV outflow tract dimension at the proximal subvalvular level
Proximal right ventricle outflow tract dimension at the proximal subvalvular level
Measured: 3 minutes
• TAPSE
- Tricuspid annular plane systolic excursion
Measured: 3 minutes
• RV free Wall strain
Right ventricle free Wall strain
Measured: 3 minutes
• Inferior cava vein PW Doppler
Inferior cava vein PW Doppler
Measured: 3 minutes
• E wave mitral
E wave mitral
Measured: 3 minutes
• A wave mitral
A wave mitral
Measured: 3 minutes
• E wave /A wave mitral
E wave /A wave mitral
Measured: 3 minutes
• E-wave at mitral annulus
E-wave at mitral annulus
Measured: 3 minutes
• E-wave at mitral annulus / A-wave at the mitral annulus
E-wave at mitral annulus / A-wave at the mitral annulus
Measured: 3 minutes
• E wave/ E-wave at the mitral annulus
E wave/ E-wave at the mitral annulus
Measured: 3 minutes
• E tricuspid (E)
E tricuspid (E)
Measured: 3 minutes
• A tricuspid (A)
A triuspid (A)
Measured: 3 minutes
• E/A
E/A
Measured: 3 minutes
• Systolic pulmonary artery pressure
Systolic pulmonary artery pressure
Measured: 3 minutes
• E-wave at the tricuspid annulus
E-wave at the tricuspid annulus
Measured: 3 minutes
• Mean pulmonary artery pressure
Mean pulmonary artery pressure
Measured: 3 minutes
• Stroke volume
Stroke volume
Measured: 3 minutes
• Cardiac output
Cardiac output
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Oct 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Echocardiography, StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miguel Ayala León
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Miguel Ayala León, Hospital Beneficencia Espanola de Puebla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498299
- Sponsor's protocol ID
- Cardiology-004
- Acronym
- ECHO-vid
- Status last verified
- Jul 2020
- First submitted
- 31 Jul 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Echocardiography in Patients Recovery From Mild COVID-19 Illness
- ClinicalTrials.gov ID
- NCT04498299
- Acronym / sponsor ID
- ECHO-vid / Cardiology-004
- Conditions
- Echocardiography, Stress, COVID-19, Hypertension, Pulmonary
- Keywords
- Echocardiography, Stress, COVID-19, Pulmonary Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Miguel Ayala LeónResearch network
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients after the resolution of acute COVID-19 illness
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- Poor acoustic window.
- Tricuspid regurgitation more than mild
- Professional sports activity
- Pregnancy
- Obesity (body mass index [BMI], ≥30 kg/m2).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echocardiogram 2DThe 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. | Diagnostic test | – |
Primary outcome
• LA volume index
Time frame: 3 minutes
Left atrium volume index
• LV telediastolic diameter
Time frame: 3 minutes
Left ventricle telediastolic diameter
• LV telesystolic diameter
Time frame: 3 minutes
Left ventricle telesystolic diameter
• LV posterior wall
Time frame: 3 minutes
Left ventricle posterior wall
• RA area
Time frame: 3 minutes
Right atrium area
• RV basal dimensión
Time frame: 3 minutes
Right ventricle basal dimensión
• RV mid cavity dimension;
Time frame: 3 minutes
Right ventricle cavity dimensión
• RV longitudinal dimension
Time frame: 3 minutes
Right ventricle longitudinal dimension
• 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
• 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
• TAPSE
Time frame: 3 minutes
• Tricuspid annular plane systolic excursion
• RV free Wall strain
Time frame: 3 minutes
Right ventricle free Wall strain
• Inferior cava vein PW Doppler
Time frame: 3 minutes
Inferior cava vein PW Doppler
• E wave mitral
Time frame: 3 minutes
E wave mitral
• A wave mitral
Time frame: 3 minutes
A wave mitral
• E wave /A wave mitral
Time frame: 3 minutes
E wave /A wave mitral
• E-wave at mitral annulus
Time frame: 3 minutes
E-wave at mitral annulus
• 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
• E wave/ E-wave at the mitral annulus
Time frame: 3 minutes
E wave/ E-wave at the mitral annulus
• E tricuspid (E)
Time frame: 3 minutes
E tricuspid (E)
• A tricuspid (A)
Time frame: 3 minutes
A triuspid (A)
• E/A
Time frame: 3 minutes
E/A
• Systolic pulmonary artery pressure
Time frame: 3 minutes
Systolic pulmonary artery pressure
• E-wave at the tricuspid annulus
Time frame: 3 minutes
E-wave at the tricuspid annulus
• Mean pulmonary artery pressure
Time frame: 3 minutes
Mean pulmonary artery pressure
• Stroke volume
Time frame: 3 minutes
Stroke volume
• Cardiac output
Time frame: 3 minutes
Cardiac output
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Echocardiography, Stress
RecruitingObservational study
Predicting Functional Recovery After Coronary Chronic Total Occlusion Revascularization
Chronic Total Occlusions of Coronary Arteries, Stress Echocardiography (SE)
RecruitingObservational study
Exercise Phenotyping Prior to Chemotherapy in Newly Diagnosed Multiple Myeloma (MM-Exercise)
Exercise Behavior, Multiple Myeloma
Not yet recruitingObservational study
Right Heart and Lung Blood Flow During Exercise (RIGHT-NET 2.0)
Right Ventricular Dysfunction, Cardiopulmonary Diseases
RecruitingObservational study
Can Exercise Electrocardiography Discriminate Hypertensive Heart Disease From Obstructive Coronary Artery Disease? A Multimodality Imaging Study
Obstructive Coronary Artery Disease, Left Ventricular Hypertrophy
Not yet recruitingObservational study
GLP-1/GIP Receptor Agonists in Obesity-Related HFpEF: The GLIDE-HF Registry
Heart Failure With Preserved Ejection Fraction, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Echocardiography, Stress and COVID-19, run by Miguel Ayala León at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact miguel ayala-leon (5529625396, terapia_intensiva_miguel@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• LA volume index (time frame: 3 minutes). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.