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CTRI Number  CTRI/2024/05/067580 [Registered on: 17/05/2024] Trial Registered Prospectively
Last Modified On: 10/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Coronary Sinus diameter as a predictor of right ventricular dysfunction 
Scientific Title of Study   Coronary Sinus diameter as a predictor of Right Ventricular dysfunction in patients undergoing Mitral Valve surgery  
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. Ram Kiran KS 
Designation  Assistant Professor  
Affiliation  UN Mehta Institute of Cardiology and Research Centre 
Address  Department of Cardiac Anesthesiology UN Mehta Institute of Cardiology and Research Institute
Asarwa, Ahmedabad, Gujarat, 380016
Ahmadabad
GUJARAT
380016
India 
Phone  9440214995  
Fax    
Email  ramkirankandala@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Rajesh VSP 
Designation  Assistant Professor  
Affiliation  UN Mehta Institute of Cardiology and Research Centre 
Address  Department of Cardiac Anesthesiology, UN Mehta Institute of Cardiology and Research Centre
Asarwa, Ahmedabad, Gujarat, 380016
Ahmadabad
GUJARAT
380016
India 
Phone  9440214995  
Fax    
Email  rajeshvsp.88@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Ram Kiran KS 
Designation  Assistant Professor  
Affiliation  UN Mehta Institute of Cardiology and Research Centre 
Address  Department of Cardiac Anesthesiology UN Mehta Institute of Cardiology and Research Centre
Asarwa, Ahmedabad, Gujarat, 380016
Ahmadabad
GUJARAT
380016
India 
Phone  9440214995  
Fax    
Email  ramkirankandala@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  UN Mehta Institute of Cardiology and Research Centre 
Address  Asarwa, AHMEDABAD, GUJARAT, 380016 
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 Ram Kiran KS  UN Mehta Institute of Cardiology and Research Centre  Department of Cardiac Anesthesiology and Research Centre
Ahmadabad
GUJARAT 
9440214995

ramkirankandala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee UN Mehta Institute of Cardiology and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I059||Rheumatic mitral valve disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients undergoing elective Mitral valve replacement without Tricuspid regurgitation or Mild to moderate Tricuspid regurgitation.
 
 
ExclusionCriteria 
Details  Patients With persistent left superior vena cava, total anomalous pulmonary venous return, coronary atrioventricular fistula, anomalous hepatic venous drainage, coronary sinus thrombosis and any postoperative coronary sinus obstruction.
Patients With Severe Tricuspid regurgitation or eccentric Tricuspid regurgitation jet towards Coronary Sinus
Patients requiring concomitant Aortic valve surgery or Coronary artery bypass graft
Patients With severe Left ventricular Dysfunction.
Patients in whom Trans esophageal echocardiography is contraindicated.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To explore the correlation between coronary sinus diameter and right ventricular dysfunction at different intervals in the postoperative period in patients who have undergone mitral valve surgery, as well as its relationship to right ventricular myocardial performance index.
 
Coronary sinus diameter is measured pre operatively and post operatively 24 hours after shifting to ICU 
 
Secondary Outcome  
Outcome  TimePoints 
Investigating the association between Vasoactive inotrope score score (VIS max), mechanical ventilation duration, ICU stay, hospital stay, & mortality is the secondary objective.
 
VIS score measured at baseline, 12 hours, 24 hours & 48 hours after shifting to ICU 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   30/05/2024 
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="1"
Months="0"
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   TITLE:   CORONARY SINUS DIAMETER AS A PREDICTOR OF RIGHT VENTRICULAR DYSFUNCTION IN PATIENTS UNDERGOING MITRAL VALVE SURGERY 
The RV function of patients going through Mitral valve surgery is affected in the early stages, and through a range of pathways. Furthermore, the application of cardiopulmonary bypass and pericardiotomy in surgical interventions weakens the natural RV contraction pattern and may lead to further impairment. RV dysfunction is a major clinical problem in the postoperative setting due to the substantial morbidity and mortality it can cause.
Intraoperatively, RV function can be judged by Echo parameters such as Tricuspid Annular Plane Systolic Excursion (TAPSE), RV Fractional Area Change (FAC), and RV Myocardial Performance Index (MPI), although they are intricate and have their own constraints.
Recent literature indicated that Coronary sinus diameter may be indicative of RV impairment in those with heart failure and in the pediatric cardiac surgery population. There is a paucity of literature available in forecasting RV dysfunction in individuals undergoing valve replacement.
AIM AND OBJECTIVES:
The main purpose of the study is to explore the correlation between coronary sinus diameter and right ventricular dysfunction at different intervals in the postoperative period in patients who have undergone mitral valve surgery, as well as its relationship to right ventricular myocardial performance index.

Investigating the association between VIS score (VIS max), mechanical ventilation duration, ICU stay, hospital stay, and mortality is the secondary objective. 
STUDY DESIGN:
It will be a prospective observational study over 1 year duration.
One hundred consenting patients going through Mitral valve surgery will be monitored for Coronary Sinus diameters at multiple points like preoperatively, after induction, just before being moved to the recovery ICU and in the postoperative period.
RVMPI ,IVC and LVEF will be measured  at same time points.
VIS Score will be calculated at various time points in the  postoperative period and VIS max will be noted, Mechanical ventilator stay, length of ICU stay, length of Hospital stay and Mortality. 
INCLUSION CRITERIA :
Age18 – 65 years
Sex- both
Patients undergoing elective Mitral valve replacement without TR or Mild to moderate TR


EXCLUSION CRITERIA :
Patients With persistent left superior vena cava, total anomalous pulmonary venous return, coronary atrioventricular fistula, anomalous hepatic venous drainage, coronary sinus thrombosis and any  postoperative  coronary sinus obstruction.
Patients With Severe TR or eccentric TR jet towards Coronary Sinus
Patients requiring concomitant  Aortic valve surgery or CABG
Patients With severe LV Dysfunction.
Patients in whom TEE is contraindicated. 
 
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