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CTRI Number  CTRI/2024/01/062110 [Registered on: 31/01/2024] Trial Registered Prospectively
Last Modified On: 29/01/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Applicability of EuroSCORE II and STS score in Indian cardiac valve surgeries  
Scientific Title of Study   Study to assess the applicability of EuroSCORE II and STS score in Indian cardiac patients undergoing valve surgeries  
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 Sanjeeta Umbarkar 
Designation  Professor (Addl) and Head of Department Cardiac Anaesthesia 
Affiliation  Seth GS medical college and KEM hospital, MUMBAI 
Address  CVTC Building, Room no. 305, Ground floor Seth GS medical College and KEM hospital, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  8879875834  
Fax    
Email  sanjeeta69@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjeeta Umbarkar 
Designation  Professor (Addl) and Head of Department Cardiac Anaesthesia 
Affiliation  Seth GS medical college and KEM hospital, MUMBAI 
Address  CVTC Building, Room no. 305, Ground floor Seth GS medical College and KEM hospital, Mumbai


MAHARASHTRA
400012
India 
Phone  8879875834  
Fax    
Email  sanjeeta69@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjeeta Umbarkar 
Designation  Professor (Addl) and Head of Department Cardiac Anaesthesia 
Affiliation  Seth GS medical college and KEM hospital, MUMBAI 
Address  CVTC Building, Room no. 305, Ground floor Seth GS medical College and KEM hospital, Mumbai


MAHARASHTRA
400012
India 
Phone  8879875834  
Fax    
Email  sanjeeta69@yahoo.com  
 
Source of Monetary or Material Support  
No funding - observational study 
Seth GS Medical College and KEM hospital, Mumbai 
 
Primary Sponsor  
Name  Seth GS medical college and KEM hospital Mumbai 
Address  Institutional ethic committee - 2, Seth GS medical college and KEM hospital, Mumbai 
Type of Sponsor  Research institution 
 
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 Sanjeeta Umbarkar  Seth GS medical college and KEM hospital, Mumbai  Second floor OT, CVTC BUILDING, Seth GS medical college and KEM hospital, Mumbai
Mumbai
MAHARASHTRA 
8879875834

sanjeeta69@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) - II, Relating to Biomedical and health research (BHR). Seth GS Medical College and KEM hospital, Mumbai, Maharashtra, India. Established - 14th November 2008  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I080||Rheumatic disorders of both mitraland aortic valves,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients between age 18 – 60 years posted for elective isolated cardiac valvular surgeries in
CVTS OT.  
 
ExclusionCriteria 
Details  1. Patient posted for double valve replacement surgeries
2. Patient undergoing CABG with valve surgeries
3. Patients not willing to participate in the study
4. Emergency valve surgeries  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1.Discharge from hospital
2.Death during hospital stay 
Till 30 days of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Dduration since first presenting symptom
Aortic cross clamp time
Total CPB time
Days to discharge from ICU 
Intraoperative period & post operative period of cardiac surgery 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   12/02/2024 
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="9"
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  

Valvular heart disease (VHD) encompasses various structural cardiac abnormalities that disrupt normal blood flow during the cardiac cycle. In low and middle socioeconomic countries like India, rheumatic heart disease (RHD) remains a significant cause of VHD-related mortality and disability, despite a decline in global numbers. Degenerative valve disease, on the other hand, has become the most prevalent form of VHD in developed countries due to the aging population. With over one million cardiac valve surgeries performed worldwide annually, the need for objective risk scoring systems for patients undergoing these surgeries has become crucial.

Accurate risk stratification of patients undergoing cardiac valve surgeries is essential for multiple purposes, including comparing institutional practices, improving treatment decision-making, cost-benefit analysis, patient counselling, and quality improvement. The 2 models currently used worldwide for cardiac surgical patients are – Society for Thoracic Surgery (STS) and the European System for Cardiac Operative Risk Evaluation II (EuroSCORE II). The STS risk score, which undergoes periodic updates, has proven highly effective for predicting mortality risk in cardiac surgical patients in the west and offers models for coronary artery bypass graft (CABG), isolated valve surgery, and valve surgery plus CABG. The EuroSCORE II is the recommended risk assessment model for cardiac surgeries globally. It predicts the probability of in-hospital mortality and was accepted for clinical use in 2011.

While institutions in India rely on either EuroSCORE II or the STS score for risk stratification, there is a lack of large-scale studies validating the applicability of these scoring systems in the Indian population, which typically presents with long standing disease, poor nutritional status and multiple associated comorbidities. Some studies have shown conflicting results regarding the accuracy of EuroSCORE II in predicting mortality in Indian patients, suggesting both under-prediction and over-prediction however limited data exists for the validation of the STS as well as EuroSCORE II in the Indian population.

In light of the challenges faced by tertiary cardiac centres in India, which cater to a growing number of patients with valvular heart diseases, the present study proposes a prospective observational analysis of valve surgery patients at a specific centre. The study will be conducted over a period of 1 year including a sample size of 200 patients undergoing cardiac valvular surgeries. Preoperative STS score will be calculated using https://riskcalc.sts.org/stswebriskcalc/calculate and EuroSCOREII will be calculated using calculator available on https://www.euroscore.org/index.php?Id=17. Other observations will be patient BMI, duration since first presenting symptom in the patient, aortic cross clamp time and total CPB time, VIS score for inotropic support after surgery, number of days for postoperative mechanical ventilation, need for reexploration, days to discharge from ICU and whether the patient had death or discharge from hospital.

 
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