| CTRI Number |
CTRI/2023/07/055228 [Registered on: 14/07/2023] Trial Registered Prospectively |
| Last Modified On: |
07/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
New Echocardiographic parameter to predict arrhythmia after heart surgery |
|
Scientific Title of Study
|
Left atrial strain as a predictor of postoperative atrial fibrillation after mitral valve replacement for mitral stenosis - A prospective observational study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jijo Francis |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Cardiac Anaesthesia and Critical Care, CNC, AIIMS New Delhi
New Delhi
DELHI
110049
India |
| Phone |
08903885758 |
| Fax |
|
| Email |
jijo925@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neeti Makhija |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Cardiac Anaesthesia and Critical Care, CNC, AIIMS, New Delhi
New Delhi
DELHI
110049
India |
| Phone |
08903885758 |
| Fax |
|
| Email |
neetimakhija@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jijo Francis |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Cardiac Anaesthesia and Critical Care, CNC, AIIMS New Delhi
New Delhi
DELHI
110049
India |
| Phone |
08903885758 |
| Fax |
|
| Email |
jijo925@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jijo Francis |
| Address |
TC 14/1202, St. George Lane, Kumarapuram, Trivandrum, Kerala 695011 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Jijo Francis |
AIIMS, New Delhi |
CTVS OT & ICU, Dept. of Cardiac Anaesthesia and Critical Care, Level 1, Cardio Neuro Centre
New Delhi
DELHI |
8903885758
jijo925@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I050||Rheumatic mitral stenosis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Posted for mitral valve surgery for mitral stenosis |
|
| ExclusionCriteria |
| Details |
Presence of moderate/ severe mitral regurgitation, presence of other valve lesions, presence of non valvular structural heart diseases, sev. LV dysfunction, h/o previous open heart surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for occurrence of atrial fibrillation |
Readings taken twice daily till 4 days post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vasoactive Inotropic Score |
Post CPB, POD 0, 1, 2, 3 |
| Duration of ICU stay, Duration of mechanical ventilation, Incidence of other adverse events |
Discharge from ICU |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/08/2023 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary objective: To study the use of left atrial strain to predict the incidence of postoperative atrial fibrillation after mitral valve replacement for mitral stenosis Secondary objective: To compare left atrial strain with several other known predictors in predicting the incidence of atrial fibrillation
LA strain is a relatively easy to perform measurement using Echocardiography. The association of LA strain with the incidence of post operative atrial fibrillation, if proved will allow us to initiate prophylaxis and be more cautious of the development of AF which could lead to improvement in morbidity and mortality in patients with mitral stenosis who undergo mitral valve replacement. |