FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/12/078517 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 24/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective, Open-label comparison 
Study Design  Other 
Public Title of Study   This study compares standard heart ultrasound with a contrast-enhanced version to assess heart function in a population of ICU patients after bypass surgery, where regular imaging is unclear. 
Scientific Title of Study   A Prospective Single Centre Open labelled Observational Study Comparing Conventional Two‐ Dimensional Transthoracic Echocardiography versus Contrast enhanced Transthoracic Echocardiography in the Assessment of Left Ventricular Volumes and Function in immediate Post operative CABG Patients with Poor Acoustic Window admitted in ICU 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Version 2.0; Dated 25/10/2024  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kaushik Sengupta 
Designation  DrNB Critical Care Medicine Resident  
Affiliation  Narayana Health 
Address  Mazumdar Shaw Medical Centre, Medical Intensive Care Unit, 2nd Floor, Narayana Health City, Bommasandra

Bangalore
KARNATAKA
560099
India 
Phone  7005223380  
Fax    
Email  kshk3333@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ratan Gupta 
Designation  Senior Consultant, Post Adult Cardiac Surgical Intensive Care 
Affiliation  Narayana Health 
Address  Narayana Hrudayalaya, Narayana Health City, Bommasandra

Bangalore
KARNATAKA
560099
India 
Phone  9845138504  
Fax    
Email  ratan.gupta.dr@narayanahealth.org  
 
Details of Contact Person
Public Query  
Name  Dr Ratan Gupta 
Designation  Senior Consultant, Post Adult Cardiac Surgical Intensive Care 
Affiliation  Narayana Health 
Address  Narayana Hrudayalaya, Narayana Health City, Bommasandra

Bangalore
KARNATAKA
560099
India 
Phone  9845138504  
Fax    
Email  ratan.gupta.dr@narayanahealth.org  
 
Source of Monetary or Material Support  
Narayana Health City, Bommasandra, Bengaluru ,India , 560099  
 
Primary Sponsor  
Name  Dr Kaushik Sengupta 
Address  Mazumdar Shaw Medical Centre, Medical Intensive Care Unit, 2nd Floor, Narayana Health City, Bommasandra, Bengaluru ,India , 560099 
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 Kaushik Sengupta  Narayana Health City  Adult Cardiac surgical ICU, 2nd Floor & 4th Floor, Dept of Intensive Care Unit ,Narayana Institute Of Cardiac Sciences
Bangalore
KARNATAKA 		 7005223380

kshk3333@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Narayana Health Academic Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I257||Atherosclerosis of coronary arterybypass graft(s) and coronary artery of transplanted heart with angina pectoris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients undergoing elective off- pump CABG.
2. Patients with poor echocardiographic image quality.
3. Age over 18 years.
4. Patients/ Guardians who will provide consent.
5. Hemodynamicaly stable patients. 
 
ExclusionCriteria 
Details  Significant ventricular arrhythmia.
Presence of intracardiac shunts.
Patients with Acute Kidney Disease.
Patients with Chronic Kidney Disease.
Patients with Chronic Liver Disease.
Patients with Cerebro Vascular Accident.
Hemodynamicaly unstable patients
Patients with mechanical assist devices.
Known allergy to contrast.
Presence of Intracardiac Shunt.
Presence of ventricular arrythmia.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the number of left ventricular segments visualized, detection of regional wall motion, and the accuracy of left ventricular volume and function estimation using both imaging techniques  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="47"
Sample Size from India="47" 
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)   06/01/2025 
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="0"
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  

The study aims to compare the efficacy and accuracy of conventional two-dimensional transthoracic echocardiography (2DE) with contrast enhanced transthoracic echocardiography in assessing left ventricular (LV) volumes and function in immediate post-operative Coronary Artery Bypass Grafting (CABG) patients with poor acoustic windows admitted to the intensive care unit (ICU).The rationale for the study lies in the challenges faced in accurately assessing LV volumes and function in these patients using conventional 2DE due to suboptimal image quality.

 
Close