| 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 |
|
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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 |
|
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
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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 |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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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 |
|
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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" |
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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. |