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CTRI Number  CTRI/2023/06/054172 [Registered on: 20/06/2023] Trial Registered Prospectively
Last Modified On: 15/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study comparing ratio of systolic movement of tricuspid valve & systolic pressure of pulmonary artery, and individual parameters separately, a factor for prognosis in patients undergoing mitral valve replacement surgery 
Scientific Title of Study   EVALUATION OF TAPSE TO PASP RATIO AS A PROGNOSTIC FACTOR IN COMPARISON WITH THE INDIVIDUAL PARAMETERS IN PATIENTS UNDERGOING MITRAL VALVE REPLACEMENT SURGERY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Elvis Senthil 
Designation  Post doctoral Trainee 
Affiliation  IPGME&R and SSKM Hospital 
Address  Department of Cardiac Anaesthesiology, IPGME&R and SSKM Hospital

Kolkata
WEST BENGAL
700020
India 
Phone  9942428075  
Fax    
Email  elvissenthil@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Chaitali Sen 
Designation  Professor and Head 
Affiliation  IPGME&R and SSKM Hospital 
Address  Department of Cardiac Anaesthesiology, IPGME&R and SSKM Hospital

Kolkata
WEST BENGAL
700020
India 
Phone  9330483007  
Fax    
Email  chaitali03@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Chaitali Sen 
Designation  Professor and Head 
Affiliation  IPGME&R and SSKM Hospital 
Address  Department of Cardiac Anaesthesiology, IPGME&R and SSKM Hospital

Kolkata
WEST BENGAL
70020
India 
Phone  9330483007  
Fax    
Email  chaitali03@rediffmail.com  
 
Source of Monetary or Material Support  
IPGME&R and SSKM Hospital 
 
Primary Sponsor  
Name  IPGME&R and SSKM Hospital 
Address  Department of Cardiac Anaesthesiology, IPGME&R and SSKM Hospital, 244 AJC Bose Road, Kolkata 700020, West Bengal 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Chaitali Sen  IPGME&R and SSKM Hospital  Cardiothoracic operating room, Department of Cardiac Anaesthesiology, IPGME&R and SSKM Hospital, 244 AJC Bose Road, Kolkata 700020
Kolkata
WEST BENGAL 
9330483007

chaitali03@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGME&R Research Oversight Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: I059||Rheumatic mitral valve disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Mitral stenosis and/or mitral regurgitation
2. Patients requiring mitral valve replacement as per ACC/AHA guidelines 
 
ExclusionCriteria 
Details  1. patient refusal
2. other cardiac ischemic and congenital lesions
3. severe AS or AR
4. severe COPD
5. CKD requiring dialysis
6. HOCM, pericardial effusion or infective endocarditis
7. emergency surgery
8. significant arrhythmias 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time to extubation  Hours after shifting to ICU (4-24 hours) 
 
Secondary Outcome  
Outcome  TimePoints 
Inotrope used  First 24 hours after shifting to ICU 
time to discharge from ICU  Time in days after shifting to ICU 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/07/2023 
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   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

OBJECTIVE OF PROPOSED RESEARCH: To assess the relevance and prognostic ability of TAPSE to PASP ratio as compared to the individual parameters in patients undergoing mitral valve replacement surgery.

BACKGROUND OF PRESENT STUDY: Patients with mitral valvular defects, both stenosis and regurgitation, often have pathology of the pulmonary circulation due to increased Left Atrial pressures. These patients are at high risk of Right Ventricular failure and frequently have Right Ventricular hypertrophy and consequent RV dysfunction. TAPSE to PASP ratio is a relatively new index which aims to better model right ventricular function in relation to the afterload experienced by the RV. This serves as a measure of RV contractility independent of the loading condition. 

METHODOLOGY: The proposed study is to be conducted under the Department of Cardiac Anaesthesiology, IPGMER & SSKM Hospital, on patients undergoing Mitral Valve Replacement Surgery. Patients meeting the inclusion criteria are selected and proper informed consent is taken after due approval of the Institutional Ethics Committee. A pre-anaesthetic check-up is performed as per routine protocols and on the day of the surgery, anaesthesia is administered and TEE probe and Pulmonary artery catheter are inserted. TAPSE and PASP values and hemodynamic parameters are recorded post induction. Time on pump, inotrope requirement, duration of surgery, urine output, time to extubation and time spent in ICU are also noted. Appropriate statistical methods are applied to the collected data to reach up to conclusion.

EXPECTED OUTCOME: Due to the importance of right ventricular function in the face of pulmonary arterial remodelling and increased afterload conditions seen with mitral valve pathology, analysis of RV function using TAPSE to PASP ratio will give us a better idea of overall cardiac function compared to measuring TAPSE or PASP alone. It is expected that the calculated ratio will have higher sensitivity and specificity compared to the individual parameters.

 
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