Myocardial performance determination through non-contact ballistocardiography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 1.To identify parameters/variables from Ballistocardiography (BCG)signal to determine Myocardial Performance Index (MPI) and Ejection Fraction (EF)
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Referred for cardiac echocardiography 2.Able to give informed consent directly or via guardian 3.Above the age of 18 years.
排除标准
- •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.
结局指标
主要结局
1.To identify parameters/variables from Ballistocardiography (BCG)signal to determine Myocardial Performance Index (MPI) and Ejection Fraction (EF)
时间窗: At Baseline
2.To calculate Myocardial Performance Index (MPI) and Left Ventricular Ejection Time (LVEF)
时间窗: At Baseline
3.To derive a signal processing framework and an adaptive predictive model algorithm for EF calculation vis-a-vis the BCG signal
时间窗: At Baseline
4.To correlate the gold standard LVEF from Biplane Simson’s Method from 2D ECHO against EF
时间窗: At Baseline
次要结局
- 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.)
