HEALTHY Clinical Trial
— TTE IN INDIANOfficial title:
Normal Echocardiographic Parameters of Indian Population and Comparison With the ASE Reference Range
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).
Status | Recruiting |
Enrollment | 150 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Age between18 to 60 years Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
India | PGIMER | Chandigarh | |
India | PGIMER | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EDLVID | End diastole left ventricle internal diameter | up to 30 minutes | |
Primary | ESLVID | End systole left ventricle internal diameter | up to 30 minutes | |
Primary | EDIVST | End diastole inter-ventricular septum thickness | up to 30 minutes | |
Primary | ESIVST | End systole inter-ventricular septum thickness | up to 30 minutes | |
Primary | EDPWT | End diastole posterior wall thickness | up to 30 minutes | |
Primary | ESPWT | End systole posterior wall thickness | up to 30 minutes | |
Primary | LVEF | Left ventricle ejection fraction | up to 30 minutes | |
Primary | LV strain | Left ventricle strain | up to 30 minutes | |
Primary | TAPSE | Tricuspid annular plane systolic excursion | up to 30 minutes | |
Primary | RV FAC | Right ventricle fractional area change | up to 30 minutes | |
Primary | RV TEI index | Right ventricle TEI index | up to 30 minutes | |
Primary | Mitral and tricuspid E',A', S' | Mitral and tricuspid annular tissue velocities | up to 30 minutes | |
Primary | RVOT diameter | Right ventricle outflow tract diameter | up to 30 minutes | |
Primary | Mitral tricuspid aortic pulmonary annulus diameter | Mitral tricuspid aortic pulmonary annulus diameter | up to 30 minutes |
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