FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/09/045859 [Registered on: 26/09/2022] Trial Registered Prospectively
Last Modified On: 26/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia
Diagnostic
Preventive
Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   We are measuring biomarker like suPAR (soluble urokinase plasminogen activated receptor) and comparing the outcome in Type 2 diabetes mellitus patients undergoing Coronary artery bypass grafting (CABG) ? 
Scientific Title of Study   Does measurement of biomarker like suPAR (soluble urokinase plasminogen activated receptor) help reduce mortality in Type 2 diabetes mellitus patients undergoing Coronary artery bypass grafting (CABG) ? 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MOHIT PRAKASH 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences,New Delhi 
Address  Cardio-neuro centre,All India Institute of Medical Sciences,New Delhi.

New Delhi
DELHI
110029
India 
Phone  09897485065  
Fax    
Email  mohitprakashdx@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Poonam Malhotra Kapoor 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences,New Delhi 
Address  All India Institute of Medical Sciences , New Delhi

New Delhi
DELHI
110029
India 
Phone  09971000741  
Fax    
Email  drpoonamaiims@gmail.com  
 
Details of Contact Person
Public Query  
Name  Poonam Malhotra Kapoor 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences,New Delhi 
Address  All India Institute of Medical Sciences , New Delhi

New Delhi
DELHI
110029
India 
Phone  09971000741  
Fax    
Email  drpoonamaiims@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences 
 
Primary Sponsor  
Name  All India Institute of Medical SciencesNew Delhi 
Address  Ansari nagar ,New Delhi 
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 
Mohit Prakash  All Institute Of Medical Sciences, New Delhi  Department of Cardiac Anaesthesiology and critical care , Cardio-neuro centre , All Institute Of Medical Sciences, New Delhi
New Delhi
DELHI 		 09897485065

mohitprakashdx@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, (2) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Measurement of biomarker  Measurement of biomarker like suPAR (soluble urokinase plasminogen activated receptor) help reduce mortality in Type 2 diabetes mellitus patients undergoing Coronary artery bypass grafting (CABG). We are measuring different biomarkers in ON pump CABG patients and see their role in prognosis.Patients will be followed till 48 hours after surgery. 
Intervention  Measurement of different biomarkers  We are measuring diiferent biomarkers including soluble urokinase plasminogen activated receptor and see their role in prognosis in On pump CABG patients 48hours after surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1 At least 18 years of age or older
2 Known case of T2DM
3 American Society of Anesthesiologists (ASA) physical status I to IV
 
 
ExclusionCriteria 
Details  1 Patients below 18 years of age
2 Patients undergoing another procedure alongwith CABG
3 Redo cardiac surgery, redo CABG
4 Emergency CABG , Off- pump CABG
5 Patients with an active ongoing infection
• Patients on cancer therapy
• Severe liver disease
• Allergies
• Connective tissue disorders
• Alcohol or other abuse
• Refusal of consent for participation
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
• To evaluate whether measurement of suPAR levels help in prognostication in patients with Type 2 Diabetes Mellitus undergoing CABG surgery   24 hours and 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. Duration of mechanical ventilation
2. Length of ICU stay
3. Vasoactive Ionotropic score
4. Post operative adverse events
5. Mortality
 		 48 hours 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   30/09/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   There have been several biomarkers searched in the past to predict cardiac injury and their role in the prognosis of the patients after cardiac event. We are also measuring different biomarkers in On Pump CABG patients and looking for their prognostic significance.The purpose of the study is to establish definite relationship between the rise of new cardiac biomarker soluble urokinase plasminogen activated receptor and its role in prgonosis of Type 2 diabetes melittus patients undergoing on pump CABG.  
Close