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CTRI Number  CTRI/2022/11/047778 [Registered on: 29/11/2022] Trial Registered Prospectively
Last Modified On: 28/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   PROSPECTIVE OBSERVATIONAL STUDY 
Study Design  Single Arm Study 
Public Title of Study   To compare left heart change in length and ecg change to predictor change in heart rhythm after heart bypass operation 
Scientific Title of Study   Comparison of left atrial strain and p wave dispersion as a predictor of postoperative atrial fibrillation in patients undergoing coronary artery bypass graft 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajmohan S 
Designation  Senior Resident 
Affiliation  All India Institute Of Medical Sciences New Delhi 
Address  Sri Aurobindo Marg Ansari Nagar Ansari Nagar East New Delhi Delhi 110029
Sri Aurobindo Marg Ansari Nagar, Ansari Nagar East New Delhi, Delhi 110029
New Delhi
DELHI
110049
India 
Phone  9582827358  
Fax    
Email  rajmd13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR ARINDAM CHOUDHURY 
Designation  ADDITIONAL PROFESSOR 
Affiliation  All India Institute Of Medical Sciences New Delhi 
Address  Department Of Cardiac Anesthesia And Critical Care Cardiothoracic And Neuro Centre All India Institute Of Medical Science New Delhi
Sri Aurobindo Marg, Ansari Nagar Ansari Nagar East New Delhi
New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  archymd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arindam Choudhury 
Designation  Additional Professor 
Affiliation  All India Institute Of Medical Sciences New Delhi 
Address  Department Of Cardiac Anesthesia And Critical Care CNC Centre Sri Aurobindo Marg, Ansari Nagar Ansari Nagar East New Delhi
Sri Aurobindo Marg, Ansari Nagar Ansari Nagar East New Delhi
New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  archymd@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences Sri Aurobindo Marg Ansari Nagar Ansari Nagar East New Delhi 110029  
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences 
Address  Sri Aurobindo Marg Ansari Nagar New Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
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 RAJMOHAN S  All India Institute Of Medical Sciences  Department Of Cardiac Anesthesiology and Critical Care Cardiothoracic centre
New Delhi
DELHI 		 9582827358

rajmd13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I798||Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All Elective Coronary Artery Bypass Graft Surgery 
 
ExclusionCriteria 
Details  1. Patients with acute coronary syndromes
2. Patients with preoperative complication of myocardial infarction (ventricular septal rupture/
LV aneurysm)
3. Patients with significant preoperative valvular heart disease
4. Patients with preoperative atrial and ventricular arrhythmias
5. Patients with preoperative cardiomyopathies
6. Patients on preoperative mechanical ventilation or dialysis
7. Previous history of cardiac surgery
8. Emergency surgery 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To compare Left Atrial Strain With P-Wave Dispersion as a predictor of postoperative atrial
fibrillation in patients undergoing coronary artery bypass graft (CABG) .
2. To find out sensitivity, specificity, threshold (cutoff point) of Left atrial strain parameters and P
wave dispersion to predict POAF in CABG 		 At Base line,after surgery and postoperative period till 3 days 
 
Secondary Outcome  
Outcome  TimePoints 
To observe hemodynamic changes,duration of intubation,length of hospital stay  At base line, After revascularization and till 3 days 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   08/12/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/10/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Postoperative atrial fibrillation (POAF) complicates 15% to 40% of cardiovascular surgeries. This arrhythmia though transient can increase the risk of embolic stroke, prolonged hospital stay and cardiovascular mortality.  Alterations in oxidative stress, calcium handling, mitochondrial dysfunction, inflammation, fibrosis, and tissue aging are among the mechanisms that predispose patients to the “atrial storm”. Manifestations of these mechanisms have been related to enlarged atria and impaired function, which can be detected prior to surgery. Alterations in the atrial reservoir and pump function, as well as atrial dyssynchrony determined by echocardiographic atrial strain, can predict POAF and help to shed light on which patients could benefit from preventive therapy. Currently, there is no one reliable way to determine preoperatively which patients will develop POAF following CABG. The aim of this study is to determine whether preoperative left atrial strain assessment and P wave dispersion can identify patients who likely to develop POAF following CABG.

 
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