| CTRI Number |
CTRI/2026/01/102031 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing heart ultrasound findings before and after surgery to measure muscle strain and predict complications in elective off-pump bypass surgery patients. |
|
Scientific Title of Study
|
Perioperative evaluation of transthoracic echocardiography derived left atrial strain using speckle-tracking: its correlation with transesophageal echocardiography derived diastolic dysfunction and postoperative adverse outcomes in elective off-pump coronary artery bypass graft surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karan |
| Designation |
DM Resident |
| Affiliation |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research, New Delhi |
| Address |
Department of Cardiac Anesthesia, Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
Central
DELHI
110002
India |
| Phone |
9416805775 |
| Fax |
|
| Email |
123karanc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjula Virmani |
| Designation |
Director Professor and Head |
| Affiliation |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research, New Delhi |
| Address |
Department of Cardiac Anesthesia, Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
Central
DELHI
110002
India |
| Phone |
9718599409 |
| Fax |
|
| Email |
drsanjulavirmani@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjula Virmani |
| Designation |
Director Professor and Head |
| Affiliation |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research, New Delhi |
| Address |
Department of Cardiac Anesthesia, Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
Central
DELHI
110002
India |
| Phone |
9718599409 |
| Fax |
|
| Email |
drsanjulavirmani@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Govind Ballabh Pant Institute of Postgraduate Medical Education and Research, New Delhi |
|
|
Primary Sponsor
|
| Name |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research |
| Address |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research, New Delhi |
| 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 |
| Dr Karan |
Govind Ballabh Pant Institute of Postgraduate Medical Education and Research |
Department of Cardiac Anesthesia, Govind Ballabh Pant Institute of Postgraduate Medical Education and Research
Central
DELHI |
09416805775
123karanc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
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 |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for elective isolated off-pump coronary artery bypass graft (CABG) surgery.
Sinus rhythm on preoperative electrocardiogram.
Adequate transthoracic echocardiographic windows for strain analysis.
Written informed consent. |
|
| ExclusionCriteria |
| Details |
On-pump CABG surgery.
Combined valve and off-pump CABG surgery.
Previous cardiac surgery.
Severe mitral or aortic valve disease (moderate-severe or severe).
Congenital heart disease.
Severe left ventricular dysfunction (Ejection fraction less than 30 percent).
Severe pulmonary hypertension (Pulmonary Artery Systolic Pressure more than 60 mmHg).
Severe renal dysfunction. (eGFR less than 30ml/min/1.73m2)
Poor echocardiographic image quality precluding strain analysis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean percentage change in left atrial strain parameters from preoperative baseline to postoperative day 7±2. |
Baseline (T0) and Postoperative Day 7±2 (T2). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relationship between preoperative LA strain parameters and preoperative TEE-based diastolic dysfunction grading. |
Baseline (T0) and Postoperative Day 7±2 (T2). |
| Incidence of postoperative atrial fibrillation (POAF). |
Baseline (T0) and Postoperative Day 7±2 (T2). |
| Incidence of low cardiac output syndrome (LCOS) requiring inotropic support. |
Baseline (T0) and Postoperative Day 7±2 (T2). |
| Incidence of acute kidney injury (AKI) stratified by KDIGO stage. |
Baseline (T0) and Postoperative Day 7±2 (T2). |
| Incidence of prolonged mechanical ventilation, defined as requirement exceeding 24 hours. |
Baseline (T0) and Postoperative Day 7±2 (T2). |
| 30-day in-hospital mortality rate. |
30 days following the surgical procedure. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
08/02/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This prospective observational study evaluates perioperative changes in 2D-speckle tracking echocardiography (STE) derived left atrial strain (LAS) in 40 patients undergoing elective off-pump CABG surgery. The study correlates preoperative Transthoracic Echocardiography (TTE)-derived LAS (reservoir, conduit, and contractile phases) with postoperative LAS values and intraoperative Transesophageal Echocardiography (TEE)-based diastolic dysfunction grading and explores its predictive value for postoperative adverse outcomes, including incidence of new-onset atrial fibrillation, low cardiac output syndrome, acute kidney injury, prolonged mechanical ventilation and low cardiac output syndrome. |