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Normal Echocardiographic Parameters of Indian Population and Comparison With the ASE Reference Range (TTE IN INDIAN)

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ClinicalTrials.gov Identifier: NCT03308383
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Ganesh Kumar Munirathinam, Postgraduate Institute of Medical Education and Research

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).

Condition or disease Intervention/treatment Phase
HEALTHY Other: DOING TRANSTHORACIC ECHOCARDIOGRAM Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Normal Echocardiographic Parameters of Indian Population and Comparison With the ASE Reference Range
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Arm Intervention/treatment
Experimental: TRANSTHORACIC ECHOCARDIOGRAM
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
TRANSTHORACIC ECHOCARDIOGRAM WILL BE DONE IN THE PARTICIPANTS WHICH IS NON-INVASIVE



Primary Outcome Measures :
  1. EDLVID [ Time Frame: up to 30 minutes ]
    End diastole left ventricle internal diameter

  2. ESLVID [ Time Frame: up to 30 minutes ]
    End systole left ventricle internal diameter

  3. EDIVST [ Time Frame: up to 30 minutes ]
    End diastole inter-ventricular septum thickness

  4. ESIVST [ Time Frame: up to 30 minutes ]
    End systole inter-ventricular septum thickness

  5. EDPWT [ Time Frame: up to 30 minutes ]
    End diastole posterior wall thickness

  6. ESPWT [ Time Frame: up to 30 minutes ]
    End systole posterior wall thickness

  7. LVEF [ Time Frame: up to 30 minutes ]
    Left ventricle ejection fraction

  8. LV strain [ Time Frame: up to 30 minutes ]
    Left ventricle strain

  9. TAPSE [ Time Frame: up to 30 minutes ]
    Tricuspid annular plane systolic excursion

  10. RV FAC [ Time Frame: up to 30 minutes ]
    Right ventricle fractional area change

  11. RV TEI index [ Time Frame: up to 30 minutes ]
    Right ventricle TEI index

  12. Mitral and tricuspid E',A', S' [ Time Frame: up to 30 minutes ]
    Mitral and tricuspid annular tissue velocities

  13. RVOT diameter [ Time Frame: up to 30 minutes ]
    Right ventricle outflow tract diameter

  14. Mitral tricuspid aortic pulmonary annulus diameter [ Time Frame: up to 30 minutes ]
    Mitral tricuspid aortic pulmonary annulus diameter



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308383


Contacts
Contact: GANESH KUMAR, MD 8968170779 mganeshkumar19@gmail.com
Contact: GOVERDHAN D PURI, MD 7087009509 gdpuri007@hotmail.com

Locations
India
PGIMER Recruiting
Chandigarh, India, 160012
Contact: GANESH KUMAR M, MD    8968170779    mganeshkumar19@gmail.com   
PGIMER Recruiting
Chandigarh, India, 160012
Contact: GANESH KUMAR, MD    8968170779    MGANESHKUMAR19@GMAIL.COM   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: GANESH KUMAR, MD PGIMER, CHANDIGARH, INDIA

Responsible Party: Ganesh Kumar Munirathinam, Principal Investigator, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03308383     History of Changes
Other Study ID Numbers: NK/3908/Study
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No