| 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 |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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] |
|
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Details of Secondary Sponsor
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|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I509||Heart failure, unspecified, |
|
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Intervention / Comparator Agent
|
|
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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.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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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 |
|
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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 |
|
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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
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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 - 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 Modelingâ€. IEEE Transactions on Biomedical Engineering, 67(10), 3001-3001.
- 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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