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

NCT04286854 | Unknown DMC

• 1 other identifier: Cardiologia-001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Echocardiography, Stress; Reference Values

Keywords

Echocardiography, Stress; Right ventricle; Mexican population

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Stress echocardiography with semi-supine bicycle DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

-The sample will be selected from a group of volunteers.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Miguel Ayala León: lead
• National Institute of Medical Sciences and Nutrition, Salvador Zubiran: collaborator

Study Sites (1)

Hospital Beneficencia Española de Puebla

Puebla City, 72090, Mexico

RECRUITING

MeSH Terms

Interventions

Echocardiography, Stress

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Miguel Ayala León, MD

CONTACT

5529625396; librocardiocritica.ma@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: cardiovascular critical care unit director

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 27, 2020
• Study Start: April 1, 2020
• Primary Completion: October 31, 2020
• Study Completion: December 31, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)