| CTRI Number |
CTRI/2020/04/024892 [Registered on: 28/04/2020] Trial Registered Prospectively |
| Last Modified On: |
22/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Imaging of lower heart cavities in patients with more than one valve heart problem |
|
Scientific Title of Study
|
Ventricular strain patterns in Multivalvular Heart Disease:A cross sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Prathiksha Prabhu |
| Designation |
MSc Echocardiography |
| Affiliation |
MCHP,MAHE,Manipal |
| Address |
2nd floor,Department of Cardiovascular Technology
MCHP,MAHE,Manipal
2nd floor,Department of Cardiovascular Technology
MCHP,MAHE,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
6363183211 |
| Fax |
|
| Email |
prathiksha1397@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwal A J |
| Designation |
MD,DM(Cardiology) |
| Affiliation |
KMC,Manipal |
| Address |
Room no 34,3rd floor OPD block,Department of Cardiology
Kasturba Hospital,Manipal
Room no 34,3rd floor OPD block,Department of Cardiology
Kasturba Hospital,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9481506690 |
| Fax |
|
| Email |
dr.ashwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K Prathiksha Prabhu |
| Designation |
MSc Echocardiography |
| Affiliation |
MCHP,MAHE,Manipal |
| Address |
2nd floor,Department of Cardiovascular Technology
MCHP,MAHE,Manipal
2nd floor,Department of Cardiovascular Technology
MCHP,MAHE,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
6363183211 |
| Fax |
|
| Email |
prathiksha1397@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiology
Kasturba Medical College and Hospital,Manipal |
|
|
Primary Sponsor
|
| Name |
Department of Cardiology |
| Address |
Kasturba 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 |
| K Prathiksha Prabhu |
Kasturba Hospital |
Room no:34,3rd floor,OPD block
Kasturba Hospital,
Manipal
Udupi
KARNATAKA |
6363183211
prathiksha1397@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Kasturba Hospital,Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I089||Rheumatic multiple valve disease,unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Multivalvular heart disease involving more than or equal to two valves with a severity of atleast more than moderate valvular lesion |
|
| ExclusionCriteria |
| Details |
Associated ischemic heart disease
LV ejection fraction <50%
Previous history of intracardiac/prosthetic heart valve intervention
Ventricular restrictive physiology(RCM) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe ventricular strain patterns in patients with multivalvular heart disease |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess ventricular ejection fraction and other demographic features in these patients(especially those with rheumatic heart disease) |
2 years |
|
|
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)
|
01/05/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is mainly done to detect subclinical myocardial deformation in patients with multivalvular heart disease using tissue deformation imaging of echocardiography.1.Primary objective:To observe left and right ventricular strain patterns in multivalvular disease. 2.Secondary objective:To assess involvement of right sided valvular lesions with aortic or mitral valvular lesions. |