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CTRI Number  CTRI/2021/12/038718 [Registered on: 17/12/2021] Trial Registered Prospectively
Last Modified On: 01/03/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Non-contact determination of heart failure 
Scientific Title of Study   Myocardial performance determination through non-contact ballistocardiography 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Surendra Deora 
Designation  Associate Professor 
Affiliation  AIIMS Jodhpur 
Address  Department of Cardiology Room no 3131 Administrative block AIIMS Jodhpur Basni Industrial Area MIA 2nd Phase Basni Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone    
Fax    
Email  drsdeora@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Pooja Kadambi 
Designation  Head, Innovation and Clinical Research 
Affiliation  Turtle Shell Technologies 
Address  Turtle Shell Technologies City Centre, 40, Ground & Mezzanine flr, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru, Karnataka 560038

Bangalore
KARNATAKA
560038
India 
Phone    
Fax    
Email  pooja@dozee.io  
 
Details of Contact Person
Public Query
 
Name  Pooja Kadambi 
Designation  Head, Innovation and Clinical Research 
Affiliation  Turtle Shell Technologies 
Address  Turtle Shell Technologies City Centre, 40, Ground & Mezzanine flr, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru, Karnataka 560038

Bangalore
KARNATAKA
560038
India 
Phone    
Fax    
Email  pooja@dozee.io  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Basni Industrial Area, MIA 2nd Phase, Basni, Jodhpur, Rajasthan 342005, India 
 
Primary Sponsor  
Name  Turtle Shell Technologies Private Limited 
Address  City Centre, #40, Ground & Mezzanine flr, Nomads Daily Huddle, Chinmaya Mission Hospital Rd, Indiranagar, Bengaluru, Karnataka 560038 
Type of Sponsor  Other [Medical Device] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Surendra Deora  AIIMS, Jodhpur  Department of Cardiology 4th floor OPD C block Room no 436 AIIMS Jodhpur Basni Industrial Area MIA 2nd Phase Basni Jodhpur 342005
Jodhpur
RAJASTHAN 
8003996715

drsdeora@gmail.com 
Dr Nishanth KR Associate Professor of Cardiology  Sri Jayadeva Institute of Cardiovascular Sciences and Research  Echocardiography Lab, Room No 5, Ground floor Jayanagar 9th Block, Bannerghetta Road, Bangalore 560069
Bangalore
KARNATAKA 
9880481530

kr.nishanth@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, Jodhpur  Approved 
Sri Jayadeva Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I509||Heart failure, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Referred for cardiac echocardiography
2. Able to give informed consent directly or via guardian
3. Above the age of 18 years
 
 
ExclusionCriteria 
Details  1. Known pregnancy
2. Spinal Implant
3. Pacemaker – single & double channel
4. Other condition that makes them unable to lie flat (severe scoliosis, injury etc.) or unable to perform SpO2.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To identify parameters/variables from Ballistocardiography (BCG)signal to determine Myocardial Performance Index (MPI) and Ejection Fraction (EF)
2. To calculate Myocardial Performance Index (MPI) and Left Ventricular Ejection Time (LVEF)
3. To derive a signal processing framework and an adaptive predictive model algorithm for EF calculation vis-a-vis the BCG signal
4. To correlate the gold standard LVEF from Biplane Simson’s Method from 2D ECHO against EF
 
At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. To identify the degree of correlation between EF and MPI calculated via the 2D TTE Echocardiography and Dozee’s novel algorithm for BCG derived EF and MPI.
2. To validate Dozee’s BCG derived EF and MPI calculation against the 2D ECHO derived EF and MPI.
3. Based on Dozee’s BCG derived EF, to be able to screen and classify participants as LV dysfunction (EF less than 45%) versus LV Normal (EF greater than 50%)
 
At Baseline 
 
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)   21/12/2021 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Ballistocardiography (BCG) records chest vibrations when the heart beats and ejects blood to peripheral blood vessels. Electrocardiogram (ECG) records the electrical activity change during each cardiac cycle by the ECG machine. Research has shown that main heart malfunctions, such as congestive heart failure and valvular disease, would alter the BCG signal, thereby yielding an excellent potential for passive, noncontact monitoring of the cardiovascular status. (Guidoboni et al., 2020) 

Turtle shell technologies Pvt Ltd (Bengaluru) have developed a device that leverages Ballistocardiography to determine individual heartbeats, breaths and body movements with high accuracy from under the patient’s mattress by capturing the micro-vibrations generated by the patient’s body. 

Nishanth et al. (2021) demonstrated the utility of Dozee’s non-contact novel BCG device in the calculation of systolic time intervals with potential for automated detection. BCG derived manual and automatic Myocardial Performance Index (MPI) correlated with Transthoracic Echocardiogram (TTE ) derived MPI in a variety of Ejection Fraction (EF)   subgroups. The study indicated that manual BCG is an effective method to measure Left Ventricular Ejection Time (LVET), Mitral Valve Closure to Opening Time (MCOT) and MPI. The evaluation of EF remains a challenging task in clinical cardiology and echocardiography. The concept of deriving a measurement like EF from another calculated measure should adhere to good clinical practice and ecologically sound research methods.

 AIM

This study proposes an exploratory model for estimating EF through a novel approach BCG signal. The study will derive a signal processing framework and an adaptive predictive model algorithm for EF calculation vis-a-vis the BCG signal. This will be a quantitative and automated measurement characterising BCG derived MPI to calculate and classify EF to screen for left ventricular heart function.

 

This study explores an agreement between EF calculated via the gold standard TTE Echocardiography and a novel algorithm for BCG derived EF. The main objective is to determine an algorithm for EF calculation with a solid  correlation to 2D-ECHO derived EF, distinguishing normal versus abnormal EF.  The clinical relevance (triaging, diagnostic, monitoring and so on) and ability to predict heart function based on characterising BCG changes will be secondary outcomes of the data collected from this study

References
  1. Guidoboni, G., Sala, L., Enayati, M., Sacco, R., Szopos, M., Keller, J. M., ... & Skubic, M. (2020). Corrections to “Cardiovascular Function and Ballistocardiogram: A Relationship Interpreted via Mathematical Modeling”. IEEE Transactions on Biomedical Engineering, 67(10), 3001-3001.
  2. Nishanth, KR, , Singh, A, Parchani, G, Kumar G,  Saran V, Manjunath C and  Padmanabhan D, (2021). A Novel Method for Measuring Myocardial Performance Index using Non-contact Ballistocardiogram System. Cardiology and Angiology: An International Journal, 10(4), 1–12


 
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