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临床试验/NCT04395014
NCT04395014Unknown不适用

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

Miguel Ayala León1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
A mitr

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

A mitr

时间窗: 3 minutes

Mitral A wave (cm/s)

Em

时间窗: 3 minutes

E-wave at mitral annulus (cm/s)

Left atrium volume index (LA volume index)

时间窗: 3 minutes

Left atrium volume index (mL/m2)

E/A tric

时间窗: 3 minutes

Tricuspid E wave/Tricuspid A wave

Left ventricular telediastolic diameter (LVTDd)

时间窗: 3 minutes

Left ventricular telediastolic diameter (mm)

Left ventricular telesystolic diamete (LVTSd)

时间窗: 3 minutes

Left ventricular telesystolic diameter (mm)

Interventricular septum (IVS)

时间窗: 3 minutes

Diameter of Interventricular septum (mm)

Left ventricular posterior wall (LVPW)

时间窗: 3 minutes

Left ventricle posterior wall (mm)

Ejection fraction (EF)

时间窗: 3 minutes

Ejection fraction (%)

Right atrium area (RA area)

时间窗: 3 minutes

Right atrium area (cm2)

Right ventricular M

时间窗: 3 minutes

Right ventricle mid cavity dimension (mm)

Right ventricular L

时间窗: 3 minutes

Right ventricle longitudinal dimension (mm)

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

时间窗: 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)

时间窗: 3 minutes

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

Tricuspid annular plane systolic excursion (TAPSE)

时间窗: 3 minutes

Tricuspid annular plane systolic excursion (mm)

Inferior cava vein (ICV)

时间窗: 3 minutes

Inferior cava vein (mm)

Sm

时间窗: 3 minutes

S-wave at mitral anulus (cm/s)

Em/Am

时间窗: 3 minutes

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

E tric

时间窗: 3 minutes

Tricuspid E wave (cm/s)

Right ventricle B

时间窗: 3 minutes

Right ventricle basal dimension (mm)

Right ventricle free wall (RV free wall)

时间窗: 3 minutes

Right ventricle free wall (mm)

E mitr

时间窗: 3 minutes

Mitral E wave (cm/s)

Am

时间窗: 3 minutes

A-wave at mitral annulus (cm/s)

E/Em

时间窗: 3 minutes

E wave/ E-wave at the mitral annulus

Et

时间窗: 3 minutes

E-wave at tricuspid anulus(cm/s)

Strain right ventricle (Strain RV)

时间窗: 3 minutes

Strain right ventricle

E/A mitr

时间窗: 3 minutes

Mitral E wave / Mitral A wave

A tric (cm/s)

时间窗: 3 minutes

Tricuspid A wave (cm/s)

St

时间窗: 3 minutes

S-wave at tricuspid anulus(cm/s)

Et/At

时间窗: 3 minutes

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

At

时间窗: 3 minutes

A-wave at tricuspid anulus (cm/s)

Mean pulmonary artery pressure (mPAP)

时间窗: 3 minutes

Mean pulmonary artery pressure (mmHg)

Systolic pulmonary artery pressure (sPAP)

时间窗: 3 minutes

Systolic pulmonary artery pressure (mmHg)

Cardiac output (CO)

时间窗: 3 minutes

Cardiac output (L/min)

Strain left ventricle (Strain LV)

时间窗: 3 minutes

Strain left ventricle

Stroke volume (SV)

时间窗: 3 minutes

Stroke volume (mL)

次要结局

未报告次要终点

研究者

发起方
Miguel Ayala León
申办方类型
Network
责任方
Sponsor Investigator
主要研究者

Miguel Ayala León

cardiovascular critical care unit director

Hospital Beneficencia Espanola de Puebla

研究点 (1)

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