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

Reference Values Clinical Trial

— ECORVStressMx  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04286854
• Other study ID #: Cardiologia-001
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2020
• Source: Hospital Beneficencia Espanola de Puebla
• Contact: Miguel Ayala León, MD
• Phone: 5529625396
• Email: librocardiocritica.ma[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Echocardiography, Stress
• Reference Values

Intervention

Diagnostic Test:
• Stress echocardiography with semi-supine bicycle
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.

Locations

Country	Name	City	State
Mexico	Hospital Beneficencia Española de Puebla	Puebla

Sponsors (2)

Lead Sponsor	Collaborator
Miguel Ayala León	National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

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 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	1 hour