Echocardiography, StressECORVStressMxNCT04286854
Echocardiographic Assessment of the Right Ventricle in Healthy Subjects During Stress Test in the Mexican Population
An observational study of Echocardiography, Stress and Reference Values, run by Miguel Ayala León at 1 site in Mexico.
Trial summary
The echocardiographic indices of the right ventricle function vary significantly with demographic and anthropometric of each population factors and are associated with poor prognosis in several cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Echocardiography, Stress, Reference Values
- What is being tested?
- Stress echocardiography with semi-supine bicycle
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- 1 Apr 2020to 31 Dec 2020
- How long will I take part?
- 1 Year
- 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
- Healthy volunteers accepted
- Adult
Study population: -The sample will be selected from a group of volunteers.
Who may be able to join
- Healthy men or women
- Age ≥18 years and < 45.
- No history or symptoms of cardiovascular or lung disease
- No cardiovascular risk factors, that is, arterial systemic hypertension, smoking, diabetes, dyslipidemia
- No ongoing or previous cardio or vasoactive treatment
- Normal ECG
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- Normal physical examination
- Able to use the semi-supine exercise bicycle
- Able to give informed consent
Who cannot join
- Tricuspid regurgitation more than mild
- Poor acoustic window.
- Professional sports activity
- Pregnancy
- Obesity (body mass index [BMI], ≥30 kg/m2).
- No knowledge of serum lipid or glucose levels at any time
- 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, librocardiocritica.ma@gmail.com
Miguel Ayala León
About this study
The echocardiographic indices of the right ventricle function vary significantly with demographic and anthropometric of each population factors and are associated with poor prognosis in several cardiovascular diseases.
This study aims to investigate exercise-induced changes in echocardiographic indices of the right ventricle function in healthy volunteers and establish the reference values to the Mexican population.
- Conditions
- Echocardiography, Stress, Reference Values
- Being tested
- Stress echocardiography with semi-supine bicycle
- Keywords
- Echocardiography, Stress, Right ventricle, Mexican population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress echocardiography with semi-supine bicycleDiagnostic test
The patient is accelerating against a workload that gradually increases at a constant rate, during the exercise the 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.
Response of diastolic and systolic function of the right ventricle during stress test by echocardiography in a healthy Mexican Cohort
The following variants will be measured by echocardiography during rest and peak exercise
Left atrium (LA)
- LA volume index Left ventricle (LV)
- LV telediastolic diameter
- LV telesystolic diameter
- LV posterior wall Right atrium (RA)
- RA area Right ventricle (RV)
- RV basal dimensión
- RV mid cavity dimension;
- RV longitudinal dimension
- Distal, RV outflow tract dimension at the distal or pulmonic valve level
- Proximal RV outflow tract dimension at the proximal subvalvular level
- Tricuspid annular plane systolic excursion
- RV free Wall strain
- Inferior cava vein PW Doppler
- E wave mitral
- A wave mitral
- E wave /A wave mitral
- E-wave at mitral annulus (cm/s)
- E-wave at mitral annulus / A-wave at the mitral annulus
- E wave/ E-wave at the mitral annulus
- E tricuspid (E)
- A tricuspid (A)
- E/A
- E-wave at the tricuspid annulus
- Systolic pulmonary artery pressure
- Mean pulmonary artery pressure
- Stroke volume
- Cardiac output
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 Apr 2020
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Dec 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
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Miguel Ayala León
- Sponsor type
- Research network
- Collaborators
- National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Responsible party
- Sponsor-investigator, Miguel Ayala León, Hospital Beneficencia Espanola de Puebla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286854
- Sponsor's protocol ID
- Cardiologia-001
- Acronym
- ECORVStressMx
- Status last verified
- Jul 2020
- First submitted
- 24 Feb 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
- Echocardiographic Assessment of the Right Ventricle in Healthy Subjects During Stress Test in the Mexican Population
- ClinicalTrials.gov ID
- NCT04286854
- Acronym / sponsor ID
- ECORVStressMx / Cardiologia-001
- Conditions
- Echocardiography, Stress, Reference Values
- Keywords
- Echocardiography, Stress, Right ventricle, Mexican population
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Miguel Ayala LeónResearch network
- Collaborators
- National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 27 Feb 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.
The echocardiographic indices of the right ventricle function vary significantly with demographic and anthropometric of each population factors and are associated with poor prognosis in several cardiovascular diseases.
This study aims to investigate exercise-induced changes in echocardiographic indices of the right ventricle function in healthy volunteers and establish the reference values to the Mexican population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- -The sample will be selected from a group of volunteers.
Key inclusion criteria (9 listed)
- Healthy men or women
- Age ≥18 years and < 45.
- No history or symptoms of cardiovascular or lung disease
- No cardiovascular risk factors, that is, arterial systemic hypertension, smoking, diabetes, dyslipidemia
- No ongoing or previous cardio or vasoactive treatment
Key exclusion criteria (7 listed)
- Tricuspid regurgitation more than mild
- Poor acoustic window.
- 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 |
|---|---|---|
| Stress echocardiography with semi-supine bicycleThe patient is accelerating against a workload that gradually increases at a constant rate, during the exercise the 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
Response of diastolic and systolic function of the right ventricle during stress test by echocardiography in a healthy Mexican Cohort
Time frame: 1 hour
The following variants will be measured by echocardiography during rest and peak exercise Left atrium (LA) * LA volume index Left ventricle (LV) * LV telediastolic diameter * LV telesystolic diameter * LV posterior wall Right atrium (RA) * RA area Right ventricle (RV) * RV basal dimensión * RV mid cavity dimension; * RV longitudinal dimension * Distal, RV outflow tract dimension at the distal or pulmonic valve level * Proximal RV outflow tract dimension at the proximal subvalvular level * Tricuspid annular plane systolic excursion * RV free Wall strain * Inferior cava vein PW Doppler * E wave mitral * A wave mitral * E wave /A wave mitral * E-wave at mitral annulus (cm/s) * E-wave at mitral annulus / A-wave at the mitral annulus * E wave/ E-wave at the mitral annulus * E tricuspid (E) * A tricuspid (A) * E/A * E-wave at the tricuspid annulus * Systolic pulmonary artery pressure * Mean pulmonary artery pressure * Stroke volume * 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
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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 Reference Values, 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 7 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 León, MD (5529625396, librocardiocritica.ma@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response of diastolic and systolic function of the right ventricle during stress test by echocardiography in a healthy Mexican Cohort (time frame: 1 hour). 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.