| CTRI Number |
CTRI/2023/07/055283 [Registered on: 17/07/2023] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of left ventricular ejection fraction obtained by using 3D echo modality called 3D EPSS with currently practiced methods of echo 2D EPSS, and 2D simpsons and 3D volumetric methods. |
|
Scientific Title of Study
|
Comparison of left ventricular ejection fraction obtained by 2D mitral E point septal separation and 3D mitral
E point septal separation linear and area methods with that of 2D and 3D volumetric methods using transesophageal echocardiography. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
V Krishna Narayanan Nayanar |
| Designation |
SR, DM Cardithoracic and vascular anaesthesia |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
SR, DM CTVA
Department of anaesthesia
SCTIMST
Trivandrum
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9419654756 |
| Fax |
|
| Email |
krishna3827@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrinivas V Gadhinglajkar |
| Designation |
Prof and HOD, Div of Cardithoracic and vascular anaesthesia |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
Department of anaesthesia
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Trivandrum
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9446304043 |
| Fax |
|
| Email |
shri@sctimst.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
V Krishna Narayanan Nayanar |
| Designation |
SR, DM Cardithoracic and vascular anaesthesia |
| Affiliation |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
| Address |
SR, DM CTVA
Department of anaesthesia
SCTIMST
Trivandrum
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9419654756 |
| Fax |
|
| Email |
krishna3827@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Chitra Tirunal Institute for Medical Sciences and Research, Medical college campus,Trivandrum, Kerala - 695011 |
|
|
Primary Sponsor
|
| Name |
Sree Chitra Tirunal Institute for Medical Sciences and Technology Trivandrum |
| Address |
Medical College Campus
Trivandrum
Kerala
Pin 695011 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| V Krishna Narayanan Nayanar |
Sree Chitra Tirunal Institute for Medical Sciences and Technology |
Adult cardiac surgery operation theatre
6th floor
C Block
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Trivandrum
Thiruvananthapuram
KERALA |
9419654756
krishna3827@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee, Sree Chitra Tirunal Institute for Medical Sciences and Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
All adults above 18 years of age, in sinus rhythm, admitted with CAD for elective CABG surgery will be included in the study. |
|
| ExclusionCriteria |
| Details |
1. Emergency surgeries
2. Redo surgeries
3. Patients not willing to participate in study
4. More than mild AR, MR or TR
5. Patients with Mitral valve pathology causing restricted or increased mobility of leaflets
6. Patients receiving preoperative inotropes
7. Patients with poor echo differentiation of endocardial borders
8. Patient with arrhythmias.
9. Contraindication to TEE probe placement like esophageal strictures, esophageal varices, esophageal
tumors, gastric ulcer, previous esophagectomy, esophageal diverticulum, tracheoesophageal fistula, previous bariatric surgery, hiatus hernia, large descending thoracic aortic aneurysm, unilateral vocal cord paralysis, esophageal varices, post-radiation therapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Comparison of 2D mitral EPSS-based LVEF & 3D mitral EPSS-based LVEF with 2D LVEF measured
from modified Simpson’s formula in patients with normal LV systolic function (LVEF more than 52% in
men & 54% in women) & their correlation with LVEF obtained by 3DE volumetric assessment as a reference method.
2. Correlation of 3D mitral EPSS area with 2DE modified Simpson’s LVEF & 3DE LVEF in patients with
good LV & deranged LV function. We also would try to derive a formula to calculate LVEF using 3D
EPSS area.
|
Pre CPB initiation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of LVEF obtained by 2D & 3D mitral EPSS, modified Simpson’s formula and their
correlation with LVEF obtained by 3DE volumetric assessment as a reference method.
i.) in patients with deranged LV systolic function
ii.) in patients without dilated LV
iii.) formula in patients with dilated LV
2. Correlation of 3D mitral EPSS area with measured LVEF in patients with dilated LV and non-dilated
LV. We also would try to derive a formula to calculate LVEF using 3D EPSS area.
3. To assess the correlation between 3D EPSS on postoperative outcome parameters
4. To ascertain the intraobserver variability and interobserver variability. |
Pre CPB initiation
Post extubation
Pre discharge from ICU |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "58"
Final Enrollment numbers achieved (India)="58" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/07/2023 |
| Date of Study Completion (India) |
31/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
Modification(s)
|
Estimation of left ventricular ejection (LVEF) fraction is an integral part of assessment of LV systolicfunction and most commonly used to assess LV systolic function, and the reduction of LVEF is seen to be associate with decreased survival rate(4).The gold standard for assessment of LVEF is using Cardiac MR(CMR) . Estimation of LVEF using modified Simpson’s biplane technique is routinely performed during cardiac surgery in the pre and post cardiopulmonary bypass period and is the currently the only recommended method for calculation of LVEF using TEE. Off all the different echo modalities used for assessment of EF, compared to CMR, 3DE currently offers the closest approximation. 3DE uses volumetric approach for acquisition of data , its visualization and quantification. This allows distance between 2 structures to be measured more accurately. Mitral EPSS is largely utilized in the emergency care for quick and reliable assessment of EF. EPSS was initially studied in 1970s as easily measured, quantitative index of LV function with a good reproducibility
Elagha A et al. studied Mitral EPSS by CMR and found that EPSS measurement by CMR is reliable and easy to perform and allows parallel assessment of LV function in both normal patients and patients having
myocardial fibrosis.Cosansu et al. was able to prove that the ratio of left ventricular internal diameter in diastole(LVIDd) with EPSS or LVIDd/EPSS was able to predict advanced HF and cases with EF<40% more
accurately .Area of separation of mitral valve from LV septal wall can be measured on 3DE. 3DE assessment of mitral EPSS and EPSS area has a potential to predict LVEF more accurately and currently remains an unstudied territory. |