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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04286854
Other study ID # Cardiologia-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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 dimensiĆ³n
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
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