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CTRI Number  CTRI/2025/11/096829 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 21/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective study 
Study Design  Single Arm Study 
Public Title of Study   Studying how the right side of the heart functions before and after off-pump bypass surgery using a special ultrasound technique called speckle tracking echocardiography. 
Scientific Title of Study   Evaluation of changes in right ventricular strain using Speckle Tracking Echocardiography in patients undergoing Off-pump coronary artery bypass grafting 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  PRASANTH D 
Designation  SENIOR RESIDENT, Cardiothoracic and vascular Anaesthesia 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum 
Address  Department of Cardiothoracic and Vascular Anaesthesiology, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Jai Nagar W Rd, Chalakkuzhi, Thiruvananthapuram, Kerala
Kumarapuram
Thiruvananthapuram
KERALA
695011
India 
Phone  9655251419  
Fax    
Email  prasanth1419@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SARAVANA BABU MS  
Designation  Additional Professor, CTVA 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum 
Address  Department of Cardiothoracic and Vascular Anaesthesiology, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Jai Nagar W Rd, Chalakkuzhi, Thiruvananthapuram, Kerala
Kumarapuram
Thiruvananthapuram
KERALA
695011
India 
Phone  8589086898  
Fax    
Email  sarvan4u@sctimst.ac.in  
 
Details of Contact Person
Public Query  
Name  SARAVANA BABU MS  
Designation  Additional Professor, CTVA 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum 
Address  Department of Cardiothoracic and Vascular Anaesthesiology, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Jai Nagar W Rd, Chalakkuzhi, Thiruvananthapuram, Kerala
Kumarapuram
Thiruvananthapuram
KERALA
695011
India 
Phone  8589086898  
Fax    
Email  sarvan4u@sctimst.ac.in  
 
Source of Monetary or Material Support  
Department of Cardiothoracic and Vascular Anaesthesiology, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Jai Nagar W Rd, Chalakkuzhi, Thiruvananthapuram, Kerala 695011, India 
 
Primary Sponsor  
Name  PRASANTH D 
Address  No. 4, Second cross street, Pudhu nagar, Thiruvandarkoil, Puducherry 605102  
Type of Sponsor  Other [SELF] 
 
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 PRASANTH D  Sree Chitra Tirunal Institute for Medical Sciences and Technology  Department of Cardiothoracic and Vascular Anaesthesiology, Sree Chitra Tirunal Institute for Medical Sciences & Technology, Jai Nagar W Rd, Chalakkuzhi, Thiruvananthapuram, Kerala 695011 Thiruvananthapuram KERALA
Thiruvananthapuram
KERALA 		 9655251419

prasanth1419@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES AND TECHNOLOGY, TRIVANDRUM INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I20-I25||Ischemic heart diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All adult patients from 18-70 years undergoing Off-pump coronary artery bypass grafting surgery. 
 
ExclusionCriteria 
Details  1.Patients refusal
2.Suboptimal echocardiographic images to interpret the results
3.Presence of associated valvular heart disease
4.Previous pacemaker implantation
5.Incomplete revascularisation,
6.Severe myocarditis,
7.Significant arrhythmia,
8.Redo surgery
9.Intraoperative decision to change into on pump
10.Patients with mild or more left ventricular dysfunction
11.Patients with right ventricular dysfunction
12.Patients who went reexploration during the hospital stay 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the changes in postoperative right ventricular strain using Speckle tracking echocardiography in patients undergoing Off-pump Coronary Artery Bypass Grafting (OPCABG) surgery.  Preoperative baseline transthoracic echo (1 day before the surgery)
post operative day zero and postoperative day 2 echo readings. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To correlate the postoperative right ventricular strain with the conventional echocardiographic parameters.
2. To evaluate the changes in the postoperative right ventricular diastolic function after Off-pump coronary artery bypass grafting surgery.
3. To analyse the changes in right ventricular strain with respect to the placement of coronary artery bypass grafts.
4. To study the changes in right ventricular strain after OPCAB in relation to postoperative outcomes like vasoactive inotropic score, incidence of atrial fibrillation, stroke, renal failure, myocardial infarction, duration of mechanical ventilation, length of ICU stay & length of hospital stay. 		 Preoperative baseline transthoracic echo (1 day before the surgery)
post operative day zero & postoperative day 2 echo readings. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/11/2025 
Date of Study Completion (India) 21/04/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
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  

A decrease in right ventricle function after coronary artery bypass grafting (CABG) during and immediately after cardiac surgery causes both morbidity and mortality and prognosis. The causes includes: pericardiotomy, myocardial stunning, pericardial adhesions impairing ventricular filling, thin walled RV may be more susceptible to dysfunction secondary to inflammation or effusions post surgery.

The most commonly used preoperative risk scores like Society of Thoracic Surgeons (STS) and EuroSCORE were not included the evaluation of right ventricular function.

To define right ventricular dysfunction - American Society of Echocardiography guidelines atleast one of following parameters: Right ventricular fractional area change (RVFAC), Doppler-derived tricuspid lateral annulus velocity (S’), Tricuspid Annular Plane Systolic Excursion (TAPSE), right myocardial performance index (RMPI). RV dysfunction suspected when TAPSE <16mm, S” <10cm/sec, RVFAC <35%, RMPI >0.55

 

Right ventricular diastolic function: American Society of Echocardiography (ASE) suggests doppler velocities of transmitral flow (E, A, E/A), tissue Doppler velocities of tricuspid annulus (E’, A’, E’/A’), decelerating time and isovolumic relaxation time (IVRT).

 

New variables emerging in evaluation of right ventricular function are Right VentricularGlobal Longitudinal Strain (RVGLS) and Right Ventricular Free Wall Longitudinal Strain (RVFWLS). Gold standard for assessing right ventricular function is echocardiography.

 
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