| CTRI Number |
CTRI/2024/04/065291 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
03/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Novel echocardiograhic parameter to assess filling pressure in patients undergoing off pump Coronary artery bypass grafting |
|
Scientific Title of Study
|
Net Atrioventricular Compliance for evaluation of LV Diastolic Function in patients undergoing off pump CABG A Prospective Observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nischitha Gowda |
| Designation |
Assistant Professor |
| Affiliation |
Sri Jayadeva institute of Cardiovascular sciences and research |
| Address |
Dept of Anaesthesiology,Cardiac OT,first floor,Sri Jayadeva institute of Cardiovascular sciences and research, Kumbara koppalu, Mysuru, Karnataka
Mysore
KARNATAKA
570016
India |
| Phone |
9660171756 |
| Fax |
|
| Email |
nischithacgowda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nischitha Gowda |
| Designation |
Assistant Professor |
| Affiliation |
Sri Jayadeva institute of Cardiovascular sciences and research |
| Address |
Dept of Anaesthesiology,Cardiac OT,first floor,Sri Jayadeva institute of Cardiovascular sciences and research, Kumbara koppalu, Mysuru, Karnataka
Mysore
KARNATAKA
570016
India |
| Phone |
9660171756 |
| Fax |
|
| Email |
nischithacgowda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nischitha Gowda |
| Designation |
Assistant Professor |
| Affiliation |
Sri Jayadeva institute of Cardiovascular sciences and research |
| Address |
Dept of Anaesthesiology, Cardiac OT,first floor,Sri Jayadeva institute of Cardiovascular sciences and research, Kumbara koppalu, Mysuru, Karnataka
Mysore
KARNATAKA
570016
India |
| Phone |
9660171756 |
| Fax |
|
| Email |
nischithacgowda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayadeva institute of Cardiovascular sciences and research, Mysuru branch, Kumbara koppalu, Mysuru, Karnataka, India 570016 |
|
|
Primary Sponsor
|
| Name |
Sri Jayadeva institute of Cardiovascular sciences and research |
| Address |
Kumbara koppalu, Mysuru, Karnataka |
| 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 Nischitha C |
Sri Jayadeva institute of Cardiovascular sciences and research Mysuru branch |
Dept of Anaesthesiology, Cardiac ot and recovery,first floor, Kumbara koppalu
Mysore
KARNATAKA |
9660171756
nischithacgowda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee -Sri jayadeva institute of Cardiovascular sciences and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective off pump Coronary artery bypass grafting |
|
| ExclusionCriteria |
| Details |
More than mild mitral regurgitation, mitral stenosis, any aortic valvulopathy more than mild grade, poor acoustic window, redo surgery, frequent atrial arrhythmias like atrial fibrillation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Grade of Diastolic dysfunction
|
Pre cabg |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ICU stay
Vis score
Mechanical ventilation duration |
Post cabg |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/04/2024 |
| 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="0"
Months="3"
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 aim of this study is to determine whether net Atrioventricular Compliance is a determinant of LV Diastolic Function in patients undergoing off pump Coronary artery bypass grafting. |