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

NCT03308383 | Unknown DMC

• 1 other identifier: NK/3908/Study
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

HEALTHY

Outcome Measures

Primary Outcomes (14)

• EDLVID

  End diastole left ventricle internal diameter

  up to 30 minutes

• ESLVID

  End systole left ventricle internal diameter

  up to 30 minutes

• EDIVST

  End diastole inter-ventricular septum thickness

  up to 30 minutes

• ESIVST

  End systole inter-ventricular septum thickness

  up to 30 minutes

• EDPWT

  End diastole posterior wall thickness

  up to 30 minutes

• ESPWT

  End systole posterior wall thickness

  up to 30 minutes

• LVEF

  Left ventricle ejection fraction

  up to 30 minutes

• LV strain

  Left ventricle strain

  up to 30 minutes

• TAPSE

  Tricuspid annular plane systolic excursion

  up to 30 minutes

• RV FAC

  Right ventricle fractional area change

  up to 30 minutes

• RV TEI index

  Right ventricle TEI index

  up to 30 minutes

• Mitral and tricuspid E',A', S'

  Mitral and tricuspid annular tissue velocities

  up to 30 minutes

• RVOT diameter

  Right ventricle outflow tract diameter

  up to 30 minutes

• Mitral tricuspid aortic pulmonary annulus diameter

  Mitral tricuspid aortic pulmonary annulus diameter

  up to 30 minutes

Study Arms (1)

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

Other: DOING TRANSTHORACIC ECHOCARDIOGRAM

Interventions

DOING TRANSTHORACIC ECHOCARDIOGRAM OTHER

TRANSTHORACIC ECHOCARDIOGRAM WILL BE DONE IN THE PARTICIPANTS WHICH IS NON-INVASIVE

TRANSTHORACIC ECHOCARDIOGRAM

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Age between18 to 60 years

You may not qualify if:

• 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)

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (2)

PGIMER

Chandigarh, 160012, India

RECRUITING

PGIMER

Chandigarh, 160012, India

RECRUITING

Study Officials

• GANESH KUMAR, MD

  PGIMER, CHANDIGARH, INDIA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GANESH KUMAR, MD

CONTACT

8968170779; mganeshkumar19@gmail.com

GOVERDHAN D PURI, MD

CONTACT

7087009509; gdpuri007@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 12, 2017
• Study Start: January 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)