| CTRI Number |
CTRI/2022/06/043226 [Registered on: 13/06/2022] Trial Registered Prospectively |
| Last Modified On: |
11/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing the strain on heart by using cardiac ultrasound scan in patients with valve disease: A Registry |
|
Scientific Title of Study
|
Myocardial deformation imaging by Speckle-tracking echocardiography in Valvular heart disease: A Clinical Registry |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asmitha G Nayak |
| Designation |
Msc. Echocardiography |
| Affiliation |
Manipal College of Health Professions |
| Address |
4-58/B Hemamajalu Anjar Gram Hiriadka
Udupi District
Post-Hiriadka
Room No 212, 2nd floor
Department of CVT
MCHP, MAHE
Manipal
576104
Udupi
KARNATAKA
576113
India |
| Phone |
7019817180 |
| Fax |
|
| Email |
asmitha.205@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnananda Nayak |
| Designation |
HOD and Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no.212, 2nd floor
Department of Cardiovascular Technology
MCHP, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9964015487 |
| Fax |
|
| Email |
krishnananda.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Krishnananda Nayak |
| Designation |
HOD & Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room No 212, 2nd floor
Department of CVT
MCHP, MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
996401587 |
| Fax |
|
| Email |
krishnananda.n@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Cardiology
KMC, Manipal |
|
|
Primary Sponsor
|
| Name |
Department of Cardiology |
| Address |
Kasturba Medical College & 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 |
| Asmitha G Nayak |
Department of Cardiology |
Room No: 34
3rd floor, OPD block
Kasturba Hospital, Manipal
Udupi
KARNATAKA |
7019817180
asmitha.205@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe-2, Kasturba Medical College and Kasturba Hospital, Manipal |
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
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All types of valvular heart disease, however for the present study, valvular heart disease with a severity of at least more than or equal to moderate will be included for the analysis
Preserved Left ventricle ejection fraction (>55%) |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To document the demographic, clinical signs and symptoms, ECG and Echocardiographic parameters in specific groups of Valvular Heart Disease. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess Left and Right ventricular strain in valvular heart disease |
1 year |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/06/2022 |
| 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)?
Response - NO
|
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Brief Summary
|
This registry will be conducted to identify various groups of Valvular Heart Disease and to study the mechanism of its effect on ventricular remodeling in preserved left ventricular ejection fraction. Furthermore, the data collected would be used to study the natural history of Valvular Heart Disease in our population. Primary objective: To document the demographic, clinical signs and symptoms, ECG, and Echocardiographic parameters in specific groups of Valvular Heart Disease. Secondary objective: To assess Left ventricular and Right ventricular function in specific groups of Valvular Heart Disease. To compare the strain between single v/s mixed v/s multi valvular lesion with respective to a particular valve.
|