| CTRI Number |
CTRI/2024/12/078544 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
To see if the diameter of the Coronary Sinus can be uses as a marker of Right Ventricular dysfunction in children undergoing surgery for Tetralogy of Fallot. |
|
Scientific Title of Study
|
Coronary Sinus diameter: Marker of Right Ventricular dysfunction in patients undergoing surgery for Tetralogy of Fallot |
| 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 Jigisha Pujara |
| Designation |
Professor |
| Affiliation |
UN Mehta Institute of Cardiology and Research Centre. |
| Address |
Room no 803, 8th Floor, Department of Cardiac Anaesthesia, A block, UN Mehta Institute of Cardiology and Research Centre
Ahmadabad
GUJARAT
380016
India |
| Phone |
9375018848 |
| Fax |
|
| Email |
jigishajayesh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Venuthurupalli SP Rajesh |
| Designation |
Assistant Professor |
| Affiliation |
UN Mehta Institute of Cardiology and Research Centre. |
| Address |
Room no 803, 8th Floor, Department of Cardiac Anaesthesia, A block, UN Mehta Institute of Cardiology and Research Centre
Ahmadabad
GUJARAT
380016
India |
| Phone |
7799026386 |
| Fax |
|
| Email |
rajeshvsp.88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Venuthurupalli SP Rajesh |
| Designation |
Assistant Professor |
| Affiliation |
UN Mehta Institute of Cardiology and Research Centre. |
| Address |
Room no 803, 8th Floor, Department of Cardiac Anaesthesia, A block, UN Mehta Institute of Cardiology and Research Centre
Ahmadabad
GUJARAT
380016
India |
| Phone |
7799026386 |
| Fax |
|
| Email |
rajeshvsp.88@gmail.com |
|
|
Source of Monetary or Material Support
|
| UN Mehta Institute of Cardiology and Research Centre, Ahmadabad, Gujarat, India, 380016 |
|
|
Primary Sponsor
|
| Name |
Dr Jigisha Pujara |
| Address |
Room no 803, 8th floor, A block, UN Mehta Institute of Cardiology and Research Centre, Ahmadabad, Gujarat, India, 380016. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Venuthurupalli SP Rajesh |
UN Mehta Institute of Cardiology and Research Centre |
Room no 803, 8th floor, A block, 380016
Ahmadabad
GUJARAT |
9712226386
rajeshvsp.88@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All childern between the age of 6 month and 18 year undergoing surgical repair for Tetralogy of Fallot under Cardiopulmonary Bypass. |
|
| ExclusionCriteria |
| Details |
Children having Tetralogy of Fallot with associated anamoly, presence of left Superior venacava, children having pre-existing renal dysfunction, children with pre-existing LV dysfunction and tricuspid regurgitation, children having a history of previous cardiac surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the association between coronary sinus diameter and RV myocardial performance index. |
preoperative, 24 hours, 48 hours post surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study the relationship between RV filling pressure and coronary sinus diameter. to study the association between RV area and coronary sinus diameter. |
preoperative, 24 hours, 48 hours post surgery |
|
|
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)
|
06/01/2025 |
| 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="8"
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
|
The deoxygenated blood from the heart is emptied into the right atrium through the coronary sinus(CS). Available literature shows relationship between coronary venous system with multiple heart pathologies like heart failure and ischemic coronary artery disease.Coronary venous system can also be treated as buffer of RV changes. Studies have shown that CS diameter has increased in patients with ischemic heart failure and might also be a part of cardiac remodeling process. In this study we aim to use CS diameter as a marker of RV dysfunction in children undergoing corrective surgery of tetralogy of fallot. |