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CTRI Number  CTRI/2025/03/082408 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 17/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   A PROSPECTIVE OBSERVATIONAL STUDY 
Study Design  Other 
Public Title of Study   Evaluation of Myocardial Strain Changes During Aortic Aneurysm Surgery Using Echocardiography 
Scientific Title of Study   Evaluation of change in Left Ventricular Global Longitudinal Strain using Transthoracic Echocardiography in the perioperative period in patients undergoing open thoracic and abdominal aortic aneurysm 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR VIGNESH I 
Designation  DM Cardiothoracic and Vascular anaesthesia 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology,  
Address  2/502 MAINROAD,PALLAKKADU(PO),SOMARASAMPETTAI,SRIRANGAM,TRICHY
2/502 MAINROAD,PALLAKKADU(PO),SOMARASAMPETTAI,SRIRANGAM,TRICHY
Tiruchirappalli
TAMIL NADU
620102
India 
Phone  8667731145  
Fax    
Email  vigneshraja2297@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DRSaravana Babu M S 
Designation  Additional Professor 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology 
Address  Department of Cardiothoracic and vascular Anaesthesiology, Sree Chitra Tirunal Institute for Medical Sciences and Technology , Trivandrum 695011

Thiruvananthapuram
KERALA
695011
India 
Phone  8589086898  
Fax    
Email  sarvn4u@sctimst.ac.in  
 
Details of Contact Person
Public Query  
Name  DRSaravana Babu M S 
Designation  Additional Professor 
Affiliation  Sree Chitra Tirunal Institute for Medical Sciences and Technology 
Address  Department of Cardiothoracic and vascular Anaesthesiology, Sree Chitra Tirunal Institute for Medical Sciences and Technology , Trivandrum 695011

Nagapattinam
KERALA
695011
India 
Phone  8589086898  
Fax    
Email  sarvn4u@sctimst.ac.in  
 
Source of Monetary or Material Support  
Sree Chitra Tirunal Institute for Medical Sciences and Technology,Thiruvananthapuram,Kerala 695011 
 
Primary Sponsor  
Name  Dr Vignesh I 
Address  2/502,Mainroad,Pallakkadu,Somarasampettai,Srirangam,Trichy(DT),PIN:620102 
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 
Vignesh I  Cardiac Surgery ICU ,Sree Chitra Tirunal Institute for Medical Sciences and Technology  Department of Cardiothoracic and vascular anaesthesia,Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala 695011
Thiruvananthapuram
KERALA 		 8667731145

vigneshraja2297@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: I716||Thoracoabdominal aortic aneurysm,without rupture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  INCLUSION CRITERIA

1) All patients above 18 years scheduled for elective open Thoraco abdominal aortic aneurysm repair.
 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA

1)Patients with other associated congenital heart anomalies.
2) Patients with significant valvular lesions.
3)Patients with severe LV dysfunction
4)Patient refusing to participate in the project
5) Poor echo image quality .
6) Emergency surgery
7)Patients undergoing Redo sternotomy, median sternotomy.
8)Patients with arrhythmia
9)Patients who were taken up for re explorations
10)Patients needing re intubation
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
• To estimate changes in left ventricular global longitudinal strain in the patients undergoing open thoracoabdominal aneurysm repair by comparing preoperative and postoperative LV GLS values.  Preoperative(Baseline),Pod 0 and Pod 1  
 
Secondary Outcome  
Outcome  TimePoints 
• To correlate LV GLS with troponin t levels, LV EF & Cardiac output measured preoperatively(Baseline) & post operatively on day 0 & 1.
• To Correlate GLS with Vasoactive inotropic score on the postoperative days 0 & 1.
• To investigate the correlation between GLS & specific postoperative outcomes, including major adverse cardiac events (MACE), duration of mechanical ventilation, length of ICU stay, length of hospital stay, & mortality.
 		 Pre Operative(Baseline),Pod 0 & Pod 1 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/04/2025 
Date of Study Completion (India) 30/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   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  

The evaluation of left ventricular (LV) function is a critical aspect of managing patients undergoing aortic aneurysm surgery. Both thoracic and abdominal aortic aneurysms pose significant risks, and surgical intervention is often the only viable option. The perioperative management of these patients is complex and necessitates thorough cardiovascular assessment to optimize outcomes.

Left ventricular global longitudinal strain (GLS) has emerged as a sensitive and reliable parameter for assessing LV systolic function. Global longitudinal Strain quantifies the myocardial deformation along the long axis of the left ventricle during systole and diastole, offering insights into myocardial contractility and relaxation. A decrease in longitudinal strain often precedes clinical symptoms, making it a sensitive indicator of early cardiac dysfunction.6This is particularly pertinent in patients undergoing major vascular surgeries, where cardiac complications are a leading cause of morbidity and mortality.

2D Speckle tracking imaging, allow for the measurement of tissue velocity and deformation, providing high-quality, precise and objective information regarding regional and/or global myocardial function in real-time. It also offers an angle-independent assessment of myocardial strain in three directions: radial, circumferential  and longitudinal9.

 

Traditional methods for analyzing LV systolic function are fractional shortening, fractional area change, stroke volume and ejection fraction (EF) derived from 2D or Doppler evaluation. Changes in LV GLS precede changes in other modalities such as EF, FAC and Stroke volume12, enabling early detection of subclinical myocardial dysfunction.

 

Patients undergoing aortic aneurysm surgery face hemodynamic instability primarily due to three factors: surgical trauma, blood loss, and a high burden of coronary atherosclerosis. This elevates the risk of perioperative cardiovascular complications, necessitating cardiac monitoring. In major surgeries, hemodynamics and cardiac function are typically monitored through clinical observations and cardiac biomarkers.  Myocardial injury , often remains asymptomatic, and is associated with an almost 10-fold increase in short-term mortality11.

 

 
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