Echocardiographic Assessment of the Right Ventricle in Healthy Subjects During Stress Test in the Mexican Population

• Conditions: Echocardiography, Stress; Reference Values

• Registration Number: NCT04286854
• Lead Sponsor: Miguel Ayala León

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-25
• Study First Posted: 2020-02-27
• Study Start: 2020-04-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-31
• Last Update Posted: 2020-08-04
• Primary Completion: 2020-10-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response of diastolic and systolic function of the right ventricle during stress test by echocardiography in a healthy Mexican Cohort	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

Trial Locations

Locations (1)

Hospital Beneficencia Española de Puebla; 🇲🇽 Puebla, Mexico