| CTRI Number |
CTRI/2018/03/012708 [Registered on: 21/03/2018] Trial Registered Prospectively |
| Last Modified On: |
16/03/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational comparative study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on changes in left atrial strain in patients with heart valve disease. |
|
Scientific Title of Study
|
Assessment of left atrial strain in patients with mitral valve disease. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Athira Radhakrishnan |
| Designation |
Intern |
| Affiliation |
School of Allied Health Sciences ,Manipal |
| Address |
Department of Cardiovascular Technology,SOAHS, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9964810982 |
| Fax |
|
| Email |
athiminnu29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMukund Prabhu |
| Designation |
Assistant Professor |
| Affiliation |
Karnataka Medical College, Manipal |
| Address |
Department of Cardiology, KMC,Manipal, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
9895137146 |
| Fax |
|
| Email |
mukundaprabhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Athira Radhakrishnan |
| Designation |
Intern |
| Affiliation |
School of Allied Health Sciences ,Manipal |
| Address |
Department of Cardiovascular technology, SOAHS, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9964810982 |
| Fax |
|
| Email |
athiminnu29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiology, Kasthurba Medical College
And Hospital Manipal. |
|
|
Primary Sponsor
|
| Name |
Department of Cardiology |
| Address |
Kasthurba Medical College and Hospital ,MAHE, Manipal |
| 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 |
| Athira Radhakrishnan |
Department of Cardiology |
Room no.34, 3rd floor, OPD block, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
9964810982
athiminnu29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasthurba Hospital , Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Mitral valve disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive patients more than 18 years of age with isolated mitral valve disease |
|
| ExclusionCriteria |
| Details |
1.Co existing aortic valve disease
2.Co existing LV dysfunction
3.Co existing ASD, 4.Co existing LVH
5.Chest wall deformation, 6. Severe PAH
7.Irregular rhythm on ECG |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| It gives information about the effect of mitral valve diseases in LA strain |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It allows the comparison of left atrial strain between patients with mitral valve disease and normal subjects |
1 year |
|
|
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)
|
30/03/2018 |
| 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 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is intended mainly to find the changes in left atrial strain pattern in patients with mitral valve disease. The main objectives are: 1)To determine left atrial strain in various mitral valve disease 2)To compare the strain pattern among these mitral valve disease |