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CTRI Number  CTRI/2024/06/069327 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On: 15/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comparision of two techniques to measure heart function in critically ill patients  
Scientific Title of Study   Relationship Of Tissue Doppler Imaging Systolic Velocity With Mitral Annular Plane Systolic Excursion And Left Ventricular Ejection Fraction By Modified Simpsons Method Using Cardiac Ultrasound An Observational Analytical Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nishant Kumar 
Designation  Professor 
Affiliation  Lady Hardinge Medical College 
Address  7th floor ICU Department of Anaesthesia Shahid Bhagat Singh Marg

New Delhi
DELHI
110001
India 
Phone  09811934659  
Fax    
Email  kumarnishant@yahoo.co.uk  
 
Details of Contact Person
Scientific Query
 
Name  Pooja Panchal 
Designation  PG Student 
Affiliation  Lady Hardinge Medical College 
Address  7th floor ICU Department of Anaesthesia Shahid Bhagat Singh Marg

New Delhi
DELHI
110001
India 
Phone  7234963067  
Fax    
Email  panchalpoojakgmu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Pooja Panchal 
Designation  PG Student 
Affiliation  Lady Hardinge Medical College 
Address  7th floor ICU Dept. of Anaesthesia Shahid Bhagat Singh Marg


DELHI
110001
India 
Phone  7234963067  
Fax    
Email  panchalpoojakgmu@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi India 110001 
 
Primary Sponsor  
Name  Lady Hardinge Medical College 
Address  Shahid Bhagat Singh Marg New Delhi India 110001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nishant Kumar  Lady Hardinge Medical College  7th Floor ICU Department of Anaesthesia Shahid Bhagat Singh Marg New Delhi 110001
New Delhi
DELHI 
9811934659

kumarnishant@yahoo.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Lady Hardinge Medical College & Associated Hospitals New Delhi 110001 India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients admitted to the intensive care unit
2. Patients more than 18 years and less than 60 years in age
3. Patients of either sex
 
 
ExclusionCriteria 
Details  1. Patients with cardiac valvular pathologies
2. Patients with poor cardiac window
3. Rhythm other than sinus
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Spearman correlation of TDI s’ with MAPSE and ejection fraction by modified Simpson’s method.  Measurements shall be made only once in one patient for the first 60 patients during the stay in ICU for the purpose of study. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Equation for the relationship between TDI s’ & left ventricular EF by Modified Simpson’s method.
2. Mean/Median time taken to measure TDI s’, MAPSE & EF by Modified Simpson’s method using 1 way ANOVA/ Friedman’s ANOVA test.
3. Comparison of ejection fraction from our equation, equation given my Matos et al [3]
and modified Simpson’s method using 1-way ANOVA test or Friedman’s test.
4. Validation of derived equation by calculating bias & precision as compared to the other two methods using Bland Altman analysis.
5. Determination of agreement of ejection fraction obtained by TDIs’, MAPSE & modified Simpson’s method.
6. Cutoff value of TDIs’ to predict low left ventricular ejection fraction using receiver operating characteristics (ROC) curve analysis. 
1. Calculations will be performed for the values obtained after first 60 patients have been recorded.
2-6. Calculations will be performed after the observations in 120 patients at the end of study
Values will be recorded at the time of diagnostic scan & only once in each patient 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2024 
Date of Study Completion (India) 29/03/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="2"
Days="6" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Point of care cardiac ultrasound is universally accepted as one of the most important tools for the assessment of the cardiac function of a patient. The ejection fraction is often taken as an indicator for left ventricular function and is a cornerstone for deciding management and interventions. However, there are various methods to assess Left ventricular ejection fraction (LVEF). The standard accepted method is the modified Simpson’s method. This entails calculation of end-diastolic volume (EDV) and end-systolic volume (ESV) from the area of left ventricle using two views, thereby calculating LVEF.  This measurement may not be accurate if the entire left ventricle is not visible, or the window is poor. It may take time to acquire the desired view, and as measurements are made in two views, precious time may be wasted, especially for an urgent assessment                                                               

Ventricular systole is a result of the contraction of longitudinal and circumferential fibers of the heart. The mitral annulus plane systolic excursion occurs as a result of the contraction of longitudinal fibers. It is hence a representative of the myocardial contractility and the ejection fraction. This displacement can be easily measured on M-mode of a cardiac ultrasound and is known as mitral annular plane systolic excursion or MAPSE.2 The average of septal and lateral movement of the mitral valve may correlate directly with myocardial contractility. It is technically easier to obtain and can even be attempted with good accuracy by an untrained hand. But it requires the lateral mitral annulus to move in the same plane of M-Mode cursor, which may be difficult to achieve under suboptimal conditions

Tissue Doppler Imaging (TDI) uses the principle of pulse wave doppler. High velocity low amplitude signals from RBCs are eliminated to display only the low velocity high amplitude signals for the myocardium. The two initial positive velocities correspond to LV isovolumic contraction velocity and peak systolic contraction velocity (s’) respectively

Peak systolic velocity is a sensitive marker of calculating Left Ventricle systolic function. TDI is technically much easier and has the lowest intra & inter observer variability. TDI s’ therefore could prove to be a reliable substitute and it could offer a choice to the clinician between the three methods for left ventricular ejection fraction assessment, which is especially advantageous in emergent conditions

 

LACUNAE IN EXISTING LITERATURE

There are only a few reported studies establishing a relationship of TDIs’ with MAPSE and LVEF, mainly in the western population with moderate success. There is no universal equation available to calculate left ventricular ejection fraction from TDI s’. This study is therefore being designed to find the relationship of TDI s’ with MAPSE and left ventricular ejection fraction measured by modified Simpson’s method and to derive and validate a generalized equation for the same.

 
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