| CTRI Number |
CTRI/2023/08/056453 [Registered on: 14/08/2023] Trial Registered Prospectively |
| Last Modified On: |
09/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the correlation of various parameters in heart ultrasound with the pumping capacity of the heart. |
|
Scientific Title of Study
|
Correlation of mitral annular plane systolic excursion with left ventricular Ejection Fraction and Global Longitudinal Strain in patients with varying degrees of left ventricular systolic dysfunction. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VASAVDATTA SHARMA |
| Designation |
REGISTRAR, DEPARTMENT OF CARDIOLOGY |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
Department of Cardiology
3rd floor
Kasturba Medical College
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9930300051 |
| Fax |
|
| Email |
vasav.chikee8@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
PADMAKUMAR R |
| Designation |
HEAD OF THE DEPARTMENT, DEPARTMENT OF CARDIOLOGY |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
Department of Cardiology
3rd floor
Kasturba Medical College
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9900921428 |
| Fax |
|
| Email |
padmakumar69@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
VASAVDATTA SHARMA |
| Designation |
REGISTRAR, DEPARTMENT OF CARDIOLOGY |
| Affiliation |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
Department of Cardiology
3rd floor
Kasturba Medical College
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9930300051 |
| Fax |
|
| Email |
vasav.chikee8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal - 576104 |
|
|
Primary Sponsor
|
| Name |
KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
KASTURBA MEDICAL COLLEGE MANIPAL - 576104 |
| 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 |
| VASAVDATTA SHARMA |
KASTURBA MEDIAL COLLEGE MANIPAL |
DEPARTMENT OF CARDIOLOGY
KASTURBA MEDICAL COLLEGE
MANIPAL Udupi KARNATAKA |
9930300051
vasav.chikee8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with varying degrees of LV systolic dysfunction, defined as LVEF less than 50 percent.
Newly diagnosed LV systolic dysfunction or previously diagnosed LV systolic dysfunction
(irrespective of therapy initiated) |
|
| ExclusionCriteria |
| Details |
Pregnancy
Not willing to give consent
Poor echogenic window |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
MAPSE & its correlation with LV systolic dysfunction & EF & global longitudinal strain.
|
1 YEAR
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MAPSE correlation with degree & severity of LV dysfunction and its correlation with diastolic dysfunction. |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
17/08/2023 |
| 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 Yet Recruiting |
| 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
|
Study will be conducted in the Department of Cardiology, Kasturba Hospital, Manipal. Patients who are diagnosed with left ventricular systolic dysfunction(new onset/previously diagnosed) and who fulfill the inclusion criteria will be included. Informed consent will be taken from the patients in the language they understand best and those willing to participate in the study after fully understanding the nature of the study and risks/benefits will be included.This is an observational, cross sectional study, in which standard echocardiographic evaluation would be done,under ECG gating, as a part of standard care of the patients with LV systolic dysfunction. Standard echocardiographic measurements will be obtained in accordance with the current guidelines of the American Society of Echocardiography/European Association of Cardiovascular Imaging.Primary outcome measured in this study will be MAPSE and its correlation with LV systolic dysfunction and EF and global longitudinal strain.Secondary outcomes will include its correlation with degree and severity of LV dysfunction, and its correlation with diastolic dysfunction.MAPSE can be used as an early and sensitive marker of LV systolic dysfunction, especially to identify such patients early. Potential risks in this study are minimal as study requires only extra parameters that will be studied in the ECHO. |