| 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
|
|
|
Primary Sponsor
|
| Name |
UN Mehta Institute of Cardiology and Research Centre |
| Address |
Asarwa, AHMEDABAD, GUJARAT, 380016 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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.
|
|
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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 |
|
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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 |
|
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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. |