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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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