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Clinical Trials/NCT04395014
NCT04395014
Unknown
Not Applicable

Echocardiographic Assessment of Ventricular Strain During a Healthy Pregnancy in the First, Second, and Third Trimester.

Miguel Ayala León1 site in 1 country50 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Echocardiography
Sponsor
Miguel Ayala León
Enrollment
50
Locations
1
Primary Endpoint
A mitr
Last Updated
5 years ago

Overview

Brief Summary

Pregnancy is a physiological situation that produces transient preload and afterload changes. The heart is subjected to reversible morphological remodelings and hemodynamic and functional adaptations. The characterization and understanding of maternal cardiac function during normal pregnancy by echocardiography 2D is of clinical importance for the opportune recognition of cardiac pathology.

This study aims to investigate pregnancy-induced changes in ventricular strain in healthy pregnant women by echocardiography.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
August 31, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Miguel Ayala León
Responsible Party
Sponsor Investigator
Principal Investigator

Miguel Ayala León

cardiovascular critical care unit director

Hospital Beneficencia Espanola de Puebla

Eligibility Criteria

Inclusion Criteria

  • Age ≥18 years and \< 35
  • Patients who coursing the first trimester of pregnancy
  • No history or symptoms of cardiovascular or lung disease
  • No ongoing or previous cardio or vasoactive treatment
  • Normal ECG
  • Normal physical examination
  • Able to give informed consent

Exclusion Criteria

  • Poor acoustic window
  • Obesity in the first trimester (body mass index \[BMI\], ≥30 kg/m2)
  • Inability to provide consent.
  • Tricuspid regurgitation more than mild
  • Collagen disease
  • Professional sports activity
  • Twin pregnancy
  • Hyperthyroidism

Outcomes

Primary Outcomes

A mitr

Time Frame: 3 minutes

Mitral A wave (cm/s)

Em

Time Frame: 3 minutes

E-wave at mitral annulus (cm/s)

Left atrium volume index (LA volume index)

Time Frame: 3 minutes

Left atrium volume index (mL/m2)

E/A tric

Time Frame: 3 minutes

Tricuspid E wave/Tricuspid A wave

Left ventricular telediastolic diameter (LVTDd)

Time Frame: 3 minutes

Left ventricular telediastolic diameter (mm)

Left ventricular telesystolic diamete (LVTSd)

Time Frame: 3 minutes

Left ventricular telesystolic diameter (mm)

Interventricular septum (IVS)

Time Frame: 3 minutes

Diameter of Interventricular septum (mm)

Left ventricular posterior wall (LVPW)

Time Frame: 3 minutes

Left ventricle posterior wall (mm)

Ejection fraction (EF)

Time Frame: 3 minutes

Ejection fraction (%)

Right atrium area (RA area)

Time Frame: 3 minutes

Right atrium area (cm2)

Right ventricular M

Time Frame: 3 minutes

Right ventricle mid cavity dimension (mm)

Right ventricular L

Time Frame: 3 minutes

Right ventricle longitudinal dimension (mm)

Right ventricle outflow tract dimension at the proximal subvalvular level (RVOT p)

Time Frame: 3 minutes

Right ventricle outflow tract dimension at the proximal subvalvular level (mm)

Right ventricle outflow tract dimension at the distal or pulmonic valve level (RVOT d)

Time Frame: 3 minutes

Right ventricle outflow tract dimension at the distal or pulmonic valve level (mm)

Tricuspid annular plane systolic excursion (TAPSE)

Time Frame: 3 minutes

Tricuspid annular plane systolic excursion (mm)

Inferior cava vein (ICV)

Time Frame: 3 minutes

Inferior cava vein (mm)

Sm

Time Frame: 3 minutes

S-wave at mitral anulus (cm/s)

Em/Am

Time Frame: 3 minutes

E-wave at mitral annulus/ A-wave at mitral annulus

E tric

Time Frame: 3 minutes

Tricuspid E wave (cm/s)

Right ventricle B

Time Frame: 3 minutes

Right ventricle basal dimension (mm)

Right ventricle free wall (RV free wall)

Time Frame: 3 minutes

Right ventricle free wall (mm)

E mitr

Time Frame: 3 minutes

Mitral E wave (cm/s)

Am

Time Frame: 3 minutes

A-wave at mitral annulus (cm/s)

E/Em

Time Frame: 3 minutes

E wave/ E-wave at the mitral annulus

Et

Time Frame: 3 minutes

E-wave at tricuspid anulus(cm/s)

Strain right ventricle (Strain RV)

Time Frame: 3 minutes

Strain right ventricle

E/A mitr

Time Frame: 3 minutes

Mitral E wave / Mitral A wave

A tric (cm/s)

Time Frame: 3 minutes

Tricuspid A wave (cm/s)

St

Time Frame: 3 minutes

S-wave at tricuspid anulus(cm/s)

Et/At

Time Frame: 3 minutes

E-wave at tricuspid anulus /A-wave at tricuspid anulus

At

Time Frame: 3 minutes

A-wave at tricuspid anulus (cm/s)

Mean pulmonary artery pressure (mPAP)

Time Frame: 3 minutes

Mean pulmonary artery pressure (mmHg)

Systolic pulmonary artery pressure (sPAP)

Time Frame: 3 minutes

Systolic pulmonary artery pressure (mmHg)

Cardiac output (CO)

Time Frame: 3 minutes

Cardiac output (L/min)

Strain left ventricle (Strain LV)

Time Frame: 3 minutes

Strain left ventricle

Stroke volume (SV)

Time Frame: 3 minutes

Stroke volume (mL)

Study Sites (1)

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