HEALTHYTTE IN INDIANNCT03308383
Normal Echocardiographic Parameters of Indian Population and Comparison With the ASE Reference Range
A study testing DOING TRANSTHORACIC ECHOCARDIOGRAM in people with HEALTHY, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HEALTHY
- What is being tested?
- DOING TRANSTHORACIC ECHOCARDIOGRAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Jan 2018to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between18 to 60 years
Who cannot join
- 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
Show all 9Show fewer
- LVH or any abnormality in ECG
- Abnormal chest X-ray
- Obesity defined by BMI MORE THAN 25 kg/m2)
Trial locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Recruiting
PGIMER
Chandigarh, 160012
GANESH KUMAR M, MD, 8968170779, mganeshkumar19@gmail.com
- Recruiting
PGIMER
Chandigarh, 160012
GANESH KUMAR, MD, 8968170779, MGANESHKUMAR19@GMAIL.COM
About this study
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).
Read the detailed description
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 :
LVEDV = 7/(2.4+LVEDD) X LVEDD3 LVESV = 7/(2.4+LVESD) X LVESD3 LV FS32 = (LVEDD-LVESD/LVEDD) x 100 LV mass in grams = 0.8x{1.04x[(IVSd+PWd+LVEDD)3 - LVIDD3]} +0.6.1 RWT = (2 X PW thickness)/ LVEDD.33
By moving the transducer cranially and medially towards sternum, and by placing M mode across the aortic sinus, perpendicular to the long axis of the aorta, LA AP diameter will be measured from leading edge to leading edge at the end of systole. From the same 2D image the aortic annulus, sino-tubular junction (STJ), aortic sinus and ascending aorta diameter will be measured from leading edge to leading edge.1 By tilting the probe from the PLAX view towards the sternum, the distal RVOT will be in view and diameter of which is measured from the leading edge to the leading edge. Proximal RVOT diameter is measured from the leading edge to the leading edge at the diastole in PSAX view in which the right ventricular (RV) inflow and outflow is visible,31 in the same view the diameter of the pulmonary valve (PV) annulus will be measured.
On palpation, the apical impulse will be identified and by placing the transducer in that point with the probe pointing toward the right shoulder, apical 4 chamber (A4C) view is obtained. The image will be optimized to get the maximum length of the LV to avoid foreshortening by identifying the pinching apex. LV end systolic volume (LVESV) and EDV and EF will be measured by Simpson's method. And by applying pulse wave Doppler with the sample volume at the tip of the mitral leaflet, mitral valve E, A velocity and deceleration time and A wave duration are calculated.
In the same image by applying Tissue Doppler (TDI) over mitral valve lateral and septal annulus e', a', S', TEI index, isovolumic relaxation time (IVRT) and isovolumic contraction time (IVCT) are calculated. TEI index is calculated using the formula (IVRT+IVCT)/ET, where ET is the ejection time. By applying M mode across the lateral annulus of the MV, mitral annular plane systolic excursion (MAPSE) is measured in cms. All the Doppler measurement will be done with the acceptable alignment between the cursor angle and movement of the tissue or blood flow (<20 degree).
Strain will be measured for both the lateral and septal wall of the LV in the same image.
By tilting the probe towards sternum and bringing the TV in the focus, the apical RV focussed view is formed. TV annulus, RV basal and mid diameter and the RV length are measured from the leading edge to the leading edge. And by applying TDI at the lateral annulus of TV e', a', s', TEI index are measured. On applying M mode across the lateral annulus, tricuspid annular plane systolic excursion (TAPSE) is measured. FAC which is measured by {RV diastolic area (DA) - RV systolic area (SA)}/ RV DA, and RV lateral wall strain are measured.
Subcostal view is obtained by placing the probe in the xiphi-sternum directing towards the left shoulder. Patient can be asked to flex the legs to make the abdominal wall relax for the placement of the probe. The RV lateral wall thickness and TV annulus diameter is measured in the subcostal 4 chamber view. And on placing the probe vertically with the pointer directed cephalad the inferior vena cava (IVC) is seen in the long axis which can be used for measuring the IVC diameter at the end expiration.
All measurements were divided by BSA for the indexed measurements. The peak of R wave and the beginning of the T wave in the ECG are used to identify the end of diastole and end of systole respectively while performing measurement.
- Conditions
- HEALTHY
- Being tested
- DOING TRANSTHORACIC ECHOCARDIOGRAM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DOING TRANSTHORACIC ECHOCARDIOGRAMOther
TRANSTHORACIC ECHOCARDIOGRAM WILL BE DONE IN THE PARTICIPANTS WHICH IS NON-INVASIVE
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: DOING TRANSTHORACIC ECHOCARDIOGRAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
EDLVID
End diastole left ventricle internal diameter
Measured: up to 30 minutes
ESLVID
End systole left ventricle internal diameter
Measured: up to 30 minutes
EDIVST
End diastole inter-ventricular septum thickness
Measured: up to 30 minutes
ESIVST
End systole inter-ventricular septum thickness
Measured: up to 30 minutes
EDPWT
End diastole posterior wall thickness
Measured: up to 30 minutes
ESPWT
End systole posterior wall thickness
Measured: up to 30 minutes
LVEF
Left ventricle ejection fraction
Measured: up to 30 minutes
LV strain
Left ventricle strain
Measured: up to 30 minutes
TAPSE
Tricuspid annular plane systolic excursion
Measured: up to 30 minutes
RV FAC
Right ventricle fractional area change
Measured: up to 30 minutes
RV TEI index
Right ventricle TEI index
Measured: up to 30 minutes
Mitral and tricuspid E',A', S'
Mitral and tricuspid annular tissue velocities
Measured: up to 30 minutes
RVOT diameter
Right ventricle outflow tract diameter
Measured: up to 30 minutes
Mitral tricuspid aortic pulmonary annulus diameter
Mitral tricuspid aortic pulmonary annulus diameter
Measured: up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start1 Jan 2018
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HEALTHYStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ganesh Kumar Munirathinam, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- GANESH KUMAR, MD, Principal investigator, PGIMER, CHANDIGARH, INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308383
- Sponsor's protocol ID
- NK/3908/Study
- Acronym
- TTE IN INDIAN
- Status last verified
- Jan 2018
- First submitted
- 27 Sep 2017
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Echocardiographic Parameters of Indian Population and Comparison With the ASE Reference Range
- ClinicalTrials.gov ID
- NCT03308383
- Acronym / sponsor ID
- TTE IN INDIAN / NK/3908/Study
- Conditions
- HEALTHY
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 12 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 :
LVEDV = 7/(2.4+LVEDD) X LVEDD3 LVESV = 7/(2.4+LVESD) X LVESD3 LV FS32 = (LVEDD-LVESD/LVEDD) x 100 LV mass in grams = 0.8x{1.04x[(IVSd+PWd+LVEDD)3 - LVIDD3]} +0.6.1 RWT = (2 X PW thickness)/ LVEDD.33
By moving the transducer cranially and medially towards sternum, and by placing M mode across the aortic sinus, perpendicular to the long axis of the aorta, LA AP diameter will be measured from leading edge to leading edge at the end of systole. From the same 2D image the aortic annulus, sino-tubular junction (STJ), aortic sinus and ascending aorta diameter will be measured from leading edge to leading edge.1 By tilting the probe from the PLAX view towards the sternum, the distal RVOT will be in view and diameter of which is measured from the leading edge to the leading edge. Proximal RVOT diameter is measured from the leading edge to the leading edge at the diastole in PSAX view in which the right ventricular (RV) inflow and outflow is visible,31 in the same view the diameter of the pulmonary valve (PV) annulus will be measured.
On palpation, the apical impulse will be identified and by placing the transducer in that point with the probe pointing toward the right shoulder, apical 4 chamber (A4C) view is obtained. The image will be optimized to get the maximum length of the LV to avoid foreshortening by identifying the pinching apex. LV end systolic volume (LVESV) and EDV and EF will be measured by Simpson's method. And by applying pulse wave Doppler with the sample volume at the tip of the mitral leaflet, mitral valve E, A velocity and deceleration time and A wave duration are calculated.
In the same image by applying Tissue Doppler (TDI) over mitral valve lateral and septal annulus e', a', S', TEI index, isovolumic relaxation time (IVRT) and isovolumic contraction time (IVCT) are calculated. TEI index is calculated using the formula (IVRT+IVCT)/ET, where ET is the ejection time. By applying M mode across the lateral annulus of the MV, mitral annular plane systolic excursion (MAPSE) is measured in cms. All the Doppler measurement will be done with the acceptable alignment between the cursor angle and movement of the tissue or blood flow (<20 degree).
Strain will be measured for both the lateral and septal wall of the LV in the same image.
By tilting the probe towards sternum and bringing the TV in the focus, the apical RV focussed view is formed. TV annulus, RV basal and mid diameter and the RV length are measured from the leading edge to the leading edge. And by applying TDI at the lateral annulus of TV e', a', s', TEI index are measured. On applying M mode across the lateral annulus, tricuspid annular plane systolic excursion (TAPSE) is measured. FAC which is measured by {RV diastolic area (DA) - RV systolic area (SA)}/ RV DA, and RV lateral wall strain are measured.
Subcostal view is obtained by placing the probe in the xiphi-sternum directing towards the left shoulder. Patient can be asked to flex the legs to make the abdominal wall relax for the placement of the probe. The RV lateral wall thickness and TV annulus diameter is measured in the subcostal 4 chamber view. And on placing the probe vertically with the pointer directed cephalad the inferior vena cava (IVC) is seen in the long axis which can be used for measuring the IVC diameter at the end expiration.
All measurements were divided by BSA for the indexed measurements. The peak of R wave and the beginning of the T wave in the ECG are used to identify the end of diastole and end of systole respectively while performing measurement.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRANSTHORACIC ECHOCARDIOGRAM | Experimental | Other: DOING TRANSTHORACIC ECHOCARDIOGRAMIndividuals 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age between18 to 60 years
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DOING TRANSTHORACIC ECHOCARDIOGRAMTRANSTHORACIC ECHOCARDIOGRAM WILL BE DONE IN THE PARTICIPANTS WHICH IS NON-INVASIVE | Other | TRANSTHORACIC ECHOCARDIOGRAM |
Primary outcome
EDLVID
Time frame: up to 30 minutes
End diastole left ventricle internal diameter
ESLVID
Time frame: up to 30 minutes
End systole left ventricle internal diameter
EDIVST
Time frame: up to 30 minutes
End diastole inter-ventricular septum thickness
ESIVST
Time frame: up to 30 minutes
End systole inter-ventricular septum thickness
EDPWT
Time frame: up to 30 minutes
End diastole posterior wall thickness
ESPWT
Time frame: up to 30 minutes
End systole posterior wall thickness
LVEF
Time frame: up to 30 minutes
Left ventricle ejection fraction
LV strain
Time frame: up to 30 minutes
Left ventricle strain
TAPSE
Time frame: up to 30 minutes
Tricuspid annular plane systolic excursion
RV FAC
Time frame: up to 30 minutes
Right ventricle fractional area change
RV TEI index
Time frame: up to 30 minutes
Right ventricle TEI index
Mitral and tricuspid E',A', S'
Time frame: up to 30 minutes
Mitral and tricuspid annular tissue velocities
RVOT diameter
Time frame: up to 30 minutes
Right ventricle outflow tract diameter
Mitral tricuspid aortic pulmonary annulus diameter
Time frame: up to 30 minutes
Mitral tricuspid aortic pulmonary annulus diameter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GANESH KUMAR, MD principal investigator
PGIMER, CHANDIGARH, INDIA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DOING TRANSTHORACIC ECHOCARDIOGRAM in people with HEALTHY, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GANESH KUMAR, MD (8968170779, mganeshkumar19@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EDLVID (time frame: up to 30 minutes). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.