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

July 31, 2020 updated by: Miguel Ayala León

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Puebla, Mexico, 72090
        • Recruiting
        • Hospital Beneficencia Española de Puebla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Miguel Ayala León

Collaborators

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2020

Primary Completion (ANTICIPATED)

October 31, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (ACTUAL)

February 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2020

Last Update Submitted That Met QC Criteria

July 31, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Cardiologia-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Reference Values

Clinical Trials on Stress echocardiography with semi-supine bicycle

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe