Normal Echocardiographic Parameters of Indian Population and Comparison With the ASE Reference Range (TTE IN INDIAN)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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 Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: GANESH KUMAR, MD
- Phone Number: 8968170779
- Email: MGANESHKUMAR19@GMAIL.COM
Study Contact Backup
- Name: GOVERDHAN D PURI, MD
- Phone Number: 7087009509
- Email: gdpuri007@hotmail.com
Study Locations
-
-
-
Chandigarh, India, 160012
- Recruiting
- PGIMER
-
Contact:
- GANESH KUMAR, MD
- Phone Number: 8968170779
- Email: MGANESHKUMAR19@GMAIL.COM
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
|
TRANSTHORACIC ECHOCARDIOGRAM WILL BE DONE IN THE PARTICIPANTS WHICH IS NON-INVASIVE
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EDLVID
Time Frame: up to 30 minutes
|
End diastole left ventricle internal diameter
|
up to 30 minutes
|
|
ESLVID
Time Frame: up to 30 minutes
|
End systole left ventricle internal diameter
|
up to 30 minutes
|
|
EDIVST
Time Frame: up to 30 minutes
|
End diastole inter-ventricular septum thickness
|
up to 30 minutes
|
|
ESIVST
Time Frame: up to 30 minutes
|
End systole inter-ventricular septum thickness
|
up to 30 minutes
|
|
EDPWT
Time Frame: up to 30 minutes
|
End diastole posterior wall thickness
|
up to 30 minutes
|
|
ESPWT
Time Frame: up to 30 minutes
|
End systole posterior wall thickness
|
up to 30 minutes
|
|
LVEF
Time Frame: up to 30 minutes
|
Left ventricle ejection fraction
|
up to 30 minutes
|
|
LV strain
Time Frame: up to 30 minutes
|
Left ventricle strain
|
up to 30 minutes
|
|
TAPSE
Time Frame: up to 30 minutes
|
Tricuspid annular plane systolic excursion
|
up to 30 minutes
|
|
RV FAC
Time Frame: up to 30 minutes
|
Right ventricle fractional area change
|
up to 30 minutes
|
|
RV TEI index
Time Frame: up to 30 minutes
|
Right ventricle TEI index
|
up to 30 minutes
|
|
Mitral and tricuspid E',A', S'
Time Frame: up to 30 minutes
|
Mitral and tricuspid annular tissue velocities
|
up to 30 minutes
|
|
RVOT diameter
Time Frame: up to 30 minutes
|
Right ventricle outflow tract diameter
|
up to 30 minutes
|
|
Mitral tricuspid aortic pulmonary annulus diameter
Time Frame: up to 30 minutes
|
Mitral tricuspid aortic pulmonary annulus diameter
|
up to 30 minutes
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: GANESH KUMAR, MD, PGIMER, Chandigarh, India
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ANTICIPATED)
Primary Completion
Study Completion (ANTICIPATED)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- NK/3908/Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HEALTHY
-
NCT06818032RecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokers
-
NCT07232121RecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult Male
-
NCT07197047CompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | Stretching
-
NCT05361343RecruitingHealthy Aging | Healthy Diet | Healthy Lifestyle
-
NCT07515417Active, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality
-
NCT03278535CompletedHealthy Volunteers | Healthy Subjects | Healthy Adults
-
NCT07520474CompletedHealthy Participants | Healthy Adult Participants | Healthy Young Adults
-
NCT05218980Not yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | Cholesterol
-
NCT07597928Not yet recruiting
-
NCT07285122RecruitingHealthy | Healthy Smoker
Clinical Trials on DOING TRANSTHORACIC ECHOCARDIOGRAM
-
NCT02548221UnknownBilateral Pleural Effusion
-
NCT02080390CompletedHer 2 Positive Breast Cancer
-
NCT02936349CompletedHereditary Hemorrhagic Telangiectasia (HHT)
-
NCT02728739CompletedMitral Regurgitation | Acute Heart Failure
-
NCT04143997WithdrawnDiastolic Dysfunction | Peripartum Cardiomyopathy
-
NCT04218578CompletedHeart Failure | Mitral Regurgitation
-
NCT02661529CompletedBidirectional Cardiovascular Shunt
-
NCT04557345CompletedAortic Valve Stenosis | Aortic Valve Disease | Aortic Valve Calcification | Prosthetic Valve Malfunction