| CTRI Number |
CTRI/2022/11/046989 [Registered on: 02/11/2022] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Calculation of Ejection Fraction from Left Heart Valve Displacement |
|
Scientific Title of Study
|
RELATIONSHIP BETWEEN MITRAL ANNULAR PLANE SYSTOLIC
EXCURSION AND LEFT VENTRICULAR EJECTION FRACTION BY
MODIFIED SIMPSON’S METHOD USING POINT OF CARE CARDIAC
ULTRASOUND: AN OBSERVATIONAL ANALYTICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ksheitij Arya |
| Designation |
Post Graduate Student |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Anaesthesia, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg
Department of Anaesthesia, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg
Central
DELHI
110001
India |
| Phone |
9315716203 |
| Fax |
|
| Email |
ksheitij.arya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishant Kumar |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Anaesthesia, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg
Department of Anaesthesia, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg
Central
DELHI
110001
India |
| Phone |
9811934659 |
| Fax |
|
| Email |
kumarnishant@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishant Kumar |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Anaesthesia, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg
Department of Anaesthesia, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg
Central
DELHI
110001
India |
| Phone |
9811934659 |
| Fax |
|
| Email |
kumarnishant@yahoo.co.uk |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesia, Lady Hardinge Medical College |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, New Delhi 110001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ksheitij Arya |
Lady Hardinge Medical College |
Shaheed Bhagat Singh Marg, New Delhi 110001
Central
DELHI |
9315716203
ksheitij.arya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee for Human Research, LHMC and Associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
|
|
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 diseases
2. Patients with poor cardiac window
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Spearman correlation between MAPSE and ejection fraction by modified Simpson’s
method |
At the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Equation for the relationship between MAPSE and left ventricular ejection fraction
2. Mean/Median time taken to measure MAPSE and left ventricular ejection fraction by modified Simpson’s method which will be compared using paired t-test or Wilcoxon
Matched-Pairs Signed Ranks Test
3. Comparison of ejection fraction from our equation, equation given my Matos et al
and modified Simpson’s method using ANOVA test or Friedman test
4. Validation of derived equation by calculating bias and precision as compared to the other two methods using Bland Altman analysis.
5. Cutoff value of MAPSE to predict low left ventricular ejection fraction using receiver operating characteristic (ROC) curve analysis. |
At the end of the study |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/11/2022 |
| Date of Study Completion (India) |
29/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/02/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="25" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Results will be published in a scientific journal |
|
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, leading to the advent of a number of different methods of assessment. The standard accepted method for this is modified Simpson’s method. This entails measurements of end-diastolic volume (EDV) and end-systolic volume (ESV) in two views from the area of left ventricle, giving the left ventricular ejection fraction (left ventricular ejection fraction). However, this takes time and may not be feasible in emergent conditions. 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. The average of septal and lateral movement of the mitral valve may correlate directly with myocardial contractility. Measurement of MAPSE offers certain advantages as compared to the modified Simpson’s method. MAPSE is technically easier to obtain when compared to modified Simpson’s method and can even be attempted with good accuracy by an untrained hand. It can be assessed even in patients with poor cardiac window as it does not rely on obtaining very specific sonographic images and is hence also quicker to assess. MAPSE therefore could prove to be a reliable substitute and it could offer a choice to the clinician between the two methods for left ventricular ejection fraction assessment, which is especially advantageous in emergent conditions and patients with poor cardiac window. A clinician will have the choice to measure only the MAPSE and still be able to predict to a certain degree of accuracy the left ventricular ejection fraction of a patient. Currently, there are very few studies on the relationship between MAPSE and ejection fraction obtained by modified Simpson’s method. Either the equation has been calculated retrospectively or in specific patient populations. There is no universal equation available to calculate left ventricular ejection fraction from MAPSE. This study is therefore being designed to find the relationship between MAPSE with left ventricular ejection fraction measured by modified Simpson’s method and to derive and validate a generalized equation for the same. |