Reference Values Clinical Trial
— ECORVStressMxOfficial title:
Echocardiographic Assessment of the Right Ventricle in Healthy Subjects During Stress Test in the Mexican Population
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2020 |
Est. primary completion date | October 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - 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 - Normal physical examination - Able to use the semi-supine exercise bicycle - Able to give informed consent Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Beneficencia Española de Puebla | Puebla |
Lead Sponsor | Collaborator |
---|---|
Miguel Ayala León | National Institute of Medical Sciences and Nutrition, Salvador Zubiran |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 dimensiĆ³n 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 |
1 hour |
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