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CTRI Number  CTRI/2019/06/019599 [Registered on: 10/06/2019] Trial Registered Prospectively
Last Modified On: 19/09/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Major Adverse Cardiac Events occurring during non cardiac surgery in cardiac patients: How accurately cardiac biomarkers predict the occurrence of these Events? 
Scientific Title of Study   Perioperative Major Adverse Cardiac Events in high risk patients undergoing major non cardiac surgeries: how accurately does pro-BNP and cardiac Troponin T predict the occurrence of major adverse cardiac events? 
Trial Acronym   
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nitika Goel 
Designation  Assistant Professor 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Fourth floor, Nehru Hospital Department of Anaesthesia Postgraduate Institute of Medical Education and Research, Chandigarh
Postgraduate Institute of Medical Education and Research Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  01722726500  
Fax    
Email  nitikagoel7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nitika Goel 
Designation  Assistant Professor 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Fourth Floor, Nehru Hospital Department of Anaesthesia Postgraduate Institute of Medical Education and Research, Chandigarh
Postgraduate Institute of Medical Education and Research Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  01722726500  
Fax    
Email  nitikagoel7@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nitika Goel 
Designation  Assistant Professor 
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh 
Address  Fourth Floor, Nehru Hospital Department of Anaesthesia Postgraduate Institute of Medical Education and Research, Chandigarh
Postgraduate Institute of Medical Education and Research Sector 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India 
Phone  01722726500  
Fax    
Email  nitikagoel7@gmail.com  
 
Source of Monetary or Material Support  
Research Grant Cell, Sixth Floor, Research Block-A Postgraduate Institute of Medical Education and Research, Chandigarh 
 
Primary Sponsor  
Name  Postgraduate Institute of Medical Education and Research Chandigarh 
Address  Research Grant Cell, Sixth Floor, Research Block A Postgraduate Institute of Medical Education and Research, Chandigarh 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Prof GD Puri  Department of Anesthesia PGIMER, Chandigarh 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nitika Goel  Postgraduate Institute of Medical Education and Research, Chandigarh  Fourth Floor, Nehru Hospital Department of Anaesthesia Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH 		 8826622159

nitikagoel7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, PGIMER, Chandigarh  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients with prior history of coronary artery disease will be defined as having any one of the following:
i) Definite CAD as indicated by a previous history of MI, typical angina or ECG changes suggestive of previous MI without a documented history of MI
ii) Patient who underwent coronary artery reperfusion therapy including previous fibrinolytic therapy, percutaneous coronary intervention and coronary angioplasty.
Patient at risk of coronary artery disease will be defined as those with age 45 yr or older and had at least one of the following major cardiac risk factors34:
1) Diabetes mellitus
2) Peripheral artery disease (i.e. intermittent claudication or history of vascular surgery except arteriovenous shunt and vein-stripping procedures)
3) History of hospitalization for congestive heart failure
4) Renal insufficiency (defined as preoperative creatinine >150 μmol litre−1)
5) History of cerebral vascular event
6) Aortic valve stenosis (defined as aortic valve area <1 cm2)
7) Atrial fibrillation
8) Moderate or poor left ventricular function (defined as left ventricular ejection fraction <55%)
 
 
ExclusionCriteria 
Details  Patients will be excluded from study participation if they had no signed informed consent.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of our study is to determine the incidence of perioperative Major Adverse Cardiac Events in cardiac patients undergoing non cardiac surgery and all cause 30 day and 1 year mortality rate in these patients.   30 days and 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome is to determine whether high sensitive cardiac troponin T or pro-BNP is more accurate in predicting Major Adverse cardiac Events.   At preoperative stage, 24 hours following surgery and 72 hours following surgery. 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   01/07/2019 
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="6"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Cardiovascular complications in the perioperative period are one of the most common events leading to increased morbidity and mortality. Major adverse cardiac events include all-cause mortality or re-hospitalization for a cardiovascular-related illness. Recently perioperative cardiac troponin I(cTnI) and NT pro BNP measurements have been used for predicting the incidence of major adverse cardiac events after emergent non cardiac surgery. The present study was planned where serial levels of NT pro BNP and cardiac Troponin T will be measured at three intervals ( preoperative, immediately postoperative and on day 3 of surgery). The diagnostic senstivity of each of these values for MACE would be assessed individually. Also the incidence of 30 day and 1 year mortality rate would be assessed in these patients.

 
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