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

NCT ID: NCT04286854

Last Updated: 2020-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Echocardiography, Stress Reference Values

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Medical Sciences and Nutrition, Salvador Zubiran

OTHER

Sponsor Role collaborator

Miguel Ayala León

NETWORK

Sponsor Role lead

Responsible Party

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Miguel Ayala León

cardiovascular critical care unit director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital Beneficencia Española de Puebla

Puebla City, , Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Miguel Ayala León, MD

Role: CONTACT

5529625396

Facility Contacts

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Miguel Ayala León, Cardiolology

Role: primary

5529625396

Other Identifiers

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Cardiologia-001

Identifier Type: -

Identifier Source: org_study_id

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