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

Echocardiography Clinical Trial

— VStrain123P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04395014
• Other study ID #: Cardiology-003
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: May 2020
• Source: Hospital Beneficencia Espanola de Puebla
• Contact: Miguel Ayala León, MD
• Phone: 5529625396
• Email: librocardiocritica.ma[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 31, 2021
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Echocardiography
• Pregnancy Complications
• Pregnancy Related Conditions, Unspecified, First Trimester
• Pregnancy Related Conditions, Unspecified, Second Trimester
• Pregnancy Related Conditions, Unspecified, Third Trimester
• Ventricle Remodeling
• Ventricular Remodeling

Intervention

Diagnostic Test:
• 2D Echocardiography
In this echocardiographic imaging acquisition protocol, the pregnancy patients, are colocated in the left lateral decubitus position on a clinical bed with the left arm flex and the hand behind the head. All the echocardiographic measurements are taken by the examiner in this position.

Locations

Country	Name	City	State
Mexico	Hospital Beneficencia Española de Puebla	Puebla

Sponsors (3)

Lead Sponsor	Collaborator
Miguel Ayala León	Institute of Security and Social Services of Workers of the State of Puebla., Leiden University Medical Center

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular telediastolic diameter (LVTDd)	Left ventricular telediastolic diameter (mm)	3 minutes
Primary	Left ventricular telesystolic diamete (LVTSd)	Left ventricular telesystolic diameter (mm)	3 minutes
Primary	Interventricular septum (IVS)	Diameter of Interventricular septum (mm)	3 minutes
Primary	Left ventricular posterior wall (LVPW)	Left ventricle posterior wall (mm)	3 minutes
Primary	Ejection fraction (EF)	Ejection fraction (%)	3 minutes
Primary	Right atrium area (RA area)	Right atrium area (cm2)	3 minutes
Primary	Right ventricle B	Right ventricle basal dimension (mm)	3 minutes
Primary	Right ventricular M	Right ventricle mid cavity dimension (mm)	3 minutes
Primary	Right ventricular L	Right ventricle longitudinal dimension (mm)	3 minutes
Primary	Right ventricle outflow tract dimension at the proximal subvalvular level (RVOT p)	Right ventricle outflow tract dimension at the proximal subvalvular level (mm)	3 minutes
Primary	Right ventricle outflow tract dimension at the distal or pulmonic valve level (RVOT d)	Right ventricle outflow tract dimension at the distal or pulmonic valve level (mm)	3 minutes
Primary	Tricuspid annular plane systolic excursion (TAPSE)	Tricuspid annular plane systolic excursion (mm)	3 minutes
Primary	Right ventricle free wall (RV free wall)	Right ventricle free wall (mm)	3 minutes
Primary	Inferior cava vein (ICV)	Inferior cava vein (mm)	3 minutes
Primary	Left atrium volume index (LA volume index)	Left atrium volume index (mL/m2)	3 minutes
Primary	E mitr	Mitral E wave (cm/s)	3 minutes
Primary	A mitr	Mitral A wave (cm/s)	3 minutes
Primary	E/A mitr	Mitral E wave / Mitral A wave	3 minutes
Primary	Sm	S-wave at mitral anulus (cm/s)	3 minutes
Primary	Em	E-wave at mitral annulus (cm/s)	3 minutes
Primary	Am	A-wave at mitral annulus (cm/s)	3 minutes
Primary	Em/Am	E-wave at mitral annulus/ A-wave at mitral annulus	3 minutes
Primary	E/Em	E wave/ E-wave at the mitral annulus	3 minutes
Primary	E tric	Tricuspid E wave (cm/s)	3 minutes
Primary	A tric (cm/s)	Tricuspid A wave (cm/s)	3 minutes
Primary	E/A tric	Tricuspid E wave/Tricuspid A wave	3 minutes
Primary	St	S-wave at tricuspid anulus(cm/s)	3 minutes
Primary	Et	E-wave at tricuspid anulus(cm/s)	3 minutes
Primary	At	A-wave at tricuspid anulus (cm/s)	3 minutes
Primary	Et/At	E-wave at tricuspid anulus /A-wave at tricuspid anulus	3 minutes
Primary	Mean pulmonary artery pressure (mPAP)	Mean pulmonary artery pressure (mmHg)	3 minutes
Primary	Systolic pulmonary artery pressure (sPAP)	Systolic pulmonary artery pressure (mmHg)	3 minutes
Primary	Stroke volume (SV)	Stroke volume (mL)	3 minutes
Primary	Cardiac output (CO)	Cardiac output (L/min)	3 minutes
Primary	Strain right ventricle (Strain RV)	Strain right ventricle	3 minutes
Primary	Strain left ventricle (Strain LV)	Strain left ventricle	3 minutes