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临床试验/NCT03308383
NCT03308383Unknown不适用

Normal Echocardiographic Parameters of Indian Population and Comparison With the ASE Reference Range

Post Graduate Institute of Medical Education and Research, Chandigarh2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
2
主要终点
ESIVST

研究概览

简要总结

Echocardiography forms one of the most used modality in the evaluation of cardiac anatomy and functions in both patients with cardiac symptoms and in healthy individuals for occupational and research purpose. The interpretation of any medical investigation including echocardiographic report is based on its comparison with the normal range for that parameter, which is known to vary depending on the age, sex, body surface area (BSA), ethnicity and race. Since most of the medical/surgical treatment decisions are made based on the echocardiographic reports, the interpretation of results should be accurate. Even though there are many studies defining reference ranges of echocardiographic parameters, most of them were based on studies conducted in Western and European population, who shows considerable difference in their anthropometric measurements from the Indian population. Hence for the accurate diagnosis of any cardiac abnormalities, the reference values should have been derived from studies conducted in population of that particular race and ethnicity who are free of risk factors for the cardiac disease. Hence the investigator planned to conduct a study to determine the normal Echocardiographic parameters and compare it with the reference range of established by American society of echocardiography (ASE).

详细描述

Aim To determine the mean and standard deviation for Echocardiographic 2 dimensional, Doppler and strain parameters in Indian population and compare it with the reference range established by ASE

Materials and Methods After getting ethical clearance and informed patient consent, the study will be performed in 150 individuals who visit pre-anaesthetic check up (PAC) clinic for minor surgery which includes plastic, rhino-otolaryngeal, ophthalmologic, orthopaedic, abdominal, urological, gynaecological surgeries, who are free of cardiac disease or any known risk factors for the cardiac disease like chronic alcoholism, chronic smoking, metabolic syndrome, morbid obesity. The duration of study will be from October 2017 to June 2018 or till 150 individual studied.

Echocardiographic Study For all the individual electrocardiogram (ECG) integrated TTE will be done using general electric (GE) Echocardiographic machine using the cardiac probe of frequency 5 Hz in supine or left lateral position in a comfortable environment. All images will be recorded as per the ASE recommendations and the images will be analysed by echo cardiographer accredited by the national board of echocardiography. Three consecutive cardiac cycles were measured and average of the three will be taken for analysis.

Image acquisition By placing the Transducer in the left third or fourth intercostal space adjacent to the sternum parasternal short axis (PSAX) view is obtained, by tilting the probe superiorly and inferiorly, the true short axis view of the LV where both the papillary muscle are seen. Parasternal long axis (PLAX) view is formed by rotating the probe perpendicular from the true PSAX view. By applying M mode across the tip of the MV in PLAX view the end diastolic, end systolic dimensions of LV, posterior wall and inter-ventricular septum thickness, relative wall thickness (RWT) and LV internal dimension will be measured from leading edge to leading edge.1 From the same image FS, LVEF by Teicholtz method, LV mass by linear cube method will be calculated.

LV EF (Teicholtz)32 :

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between18 to 60 years

排除标准

  • History of congenital or acquired cardiac abnormality
  • Symptoms and Signs suggestive of any cardio-respiratory disease
  • Systemic hypertension SBP more than 140 and DBP more than90
  • Known case of Diabetes mellitus or signs and symptoms suggesting like polyuria, polydipsia, autonomic dysfunction
  • History of long term exercise
  • Systemic disease like chronic kidney disease, chronic liver disease, chronic obstructive pulmonary disease
  • LVH or any abnormality in ECG
  • Abnormal chest X-ray
  • Obesity defined by BMI MORE THAN 25 kg/m2)

研究组 & 干预措施

TRANSTHORACIC ECHOCARDIOGRAM

Experimental

Individuals who visit pre-anaesthetic check up (PAC) clinic for minor surgery which includes plastic, rhino-otolaryngeal, ophthalmologic, orthopaedic, abdominal, urological, gynaecological surgeries, who are free of cardiac disease or any known risk factors for the cardiac disease like chronic alcoholism, chronic smoking, metabolic syndrome, morbid obesity

干预措施: DOING TRANSTHORACIC ECHOCARDIOGRAM (Other)

结局指标

主要结局

ESIVST

时间窗: up to 30 minutes

End systole inter-ventricular septum thickness

RV FAC

时间窗: up to 30 minutes

Right ventricle fractional area change

EDIVST

时间窗: up to 30 minutes

End diastole inter-ventricular septum thickness

ESLVID

时间窗: up to 30 minutes

End systole left ventricle internal diameter

EDPWT

时间窗: up to 30 minutes

End diastole posterior wall thickness

Mitral tricuspid aortic pulmonary annulus diameter

时间窗: up to 30 minutes

Mitral tricuspid aortic pulmonary annulus diameter

EDLVID

时间窗: up to 30 minutes

End diastole left ventricle internal diameter

LV strain

时间窗: up to 30 minutes

Left ventricle strain

TAPSE

时间窗: up to 30 minutes

Tricuspid annular plane systolic excursion

Mitral and tricuspid E',A', S'

时间窗: up to 30 minutes

Mitral and tricuspid annular tissue velocities

RVOT diameter

时间窗: up to 30 minutes

Right ventricle outflow tract diameter

ESPWT

时间窗: up to 30 minutes

End systole posterior wall thickness

LVEF

时间窗: up to 30 minutes

Left ventricle ejection fraction

RV TEI index

时间窗: up to 30 minutes

Right ventricle TEI index

次要结局

未报告次要终点

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ganesh Kumar Munirathinam

Principal Investigator

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (2)

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