| CTRI Number |
CTRI/2024/11/077159 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Advanced heart Imaging during cardiac surgery |
|
Scientific Title of Study
|
Validation of Intraoperative 3D Transesophageal Echocardiography Derived Ventricular Volumes and Ejection Fraction in Adults with Cardiac MRI: Prospective Non-Randomized Interventional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sathya Narayan R |
| Designation |
Academic Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Room No.409,
Academic Block
AIIMS Bhubaneswar
Bhubaneswar, Sijua, Patrapada
Khordha
ORISSA
751019
India |
| Phone |
8072922076 |
| Fax |
|
| Email |
likablesathya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyajeet Misra |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Room No 409, Academic Block
AIIMS Bhubaneswar
Khordha
Khordha
ORISSA
751019
India |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satyajeet Misra |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Room No 409, Academic Block
AIIMS Bhubaneswar
Khordha
Khordha
ORISSA
751019
India |
| Phone |
9438884048 |
| Fax |
|
| Email |
misrasatyajeet@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhubaneswar, Bhubaneswar, 751019, Odisha |
|
|
Primary Sponsor
|
| Name |
Dr Haasith Dara |
| Address |
Room No 409, Academic Block
AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Type of Sponsor |
Other [Individual] |
|
|
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 |
| Dr Satyajeet Misra |
AIIMS Bhubaneswar |
CTVS OT Complex, First floor, AIIMS Bhubaneswar
Khordha
ORISSA |
9438884048
misrasatyajeet@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee All India Institute of Medical Sciences Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cardiac MRI |
Cardiac MRI derived parameters duration - 40 mins |
| Intervention |
Trans thoracic echocardiography |
3D Transthoracic Echocardiography derived parameters for a duration of 10 mins |
| Intervention |
Transesophageal Echocardiography |
3D Transesophageal Echocardiography derived Parameters for a duration of 10 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients posted electively for CABG, valve replacements/repair or ASD closure with optimal images for transthoracic and transesophageal echocardiography. |
|
| ExclusionCriteria |
| Details |
1. Patients with arrhythmia.
2. Contra-indication to TEE probe placement.
3. Patients undergoing emergency surgery.
4. Patients undergoing re-do surgeries.
5. Patients with change in symptomatology between cardiac magnetic resonance imaging and surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation of 3-dimensional Transesophageal Echocardiography (TEE) -derived LV volumes, EF and mass; and RV volumes and EF with Cardiac MRI (CMR). |
Baseline
Intraoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the correlation of 3D TEE-derived LV volumes, EF & mass; & RV volumes & EF with 3D TTE. |
Intraoperative |
To assess the intra-class correlation of 3D TEE at the following time points.
|
Intraoperative |
|
|
Target Sample Size
|
Total Sample Size="17"
Sample Size from India="17"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
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)
|
Accurate intraoperative assessment of cardiac function is crucial for optimizing perioperative management in cardiac surgery. Left ventricular (LV) volumes and ejection fraction (EF) are essential for evaluating myocardial contractility, while right ventricular (RV) assessment is important for understanding pulmonary circulation dynamics. Transesophageal echocardiography (TEE) is the standard imaging tool used in these settings, but traditional two-dimensional (2D) TEE has limitations, including geometric assumptions and suboptimal resolution, leading to variability in measurements. 3-dimensional TEE is superior to 2D TEE as it does not have any limitations of geometric assumptions. However, until now, 3D TEE has not been validated with the gold standard cardiac MRI. This trial aims to validate the measurements obtained from intraoperative 3D TEE with cardiac magnetic resonance imaging (CMR), for assessing ventricular volumes and EF. The goal of this study is to establish the accuracy and reliability of 3D TEE measurements in the intraoperative context. |