Final Report Summary - HEARTRONIC (HEART Rating for Objective Neural Intelligent Communication)
The HEARTRONIC project aimed to develop an innovative system for prevention and early warning by a continuous monitoring of heart conditions, integrated in a wearable and light support like a shirt, capable to recognise cardiovascular anomalies and to alert doctors and hospitals in real time. The easy but extremely innovative project concept, based on the integration of the system on board and the patient's mobile phone that allows automatic communication with doctors and Public Health without any physical nor distance limitation. The novelty of the approach consisted in the almost total elimination of a mass storage device for data storage; this implied sending data over a wireless network in real time. This could be done only by screening the signals on board and transmitting a limited amount of abnormal tracks, miniaturizing the neural classification system.
The HEARTRONIC system was composed by:
- Data Acquisition Unit: reads signals from the chest and performs the first diagnosis inside the elaboration unit, composed by a high-end DSP. The digital MEMS accelerometer/inclinometer helps the ECG pattern recognition algorithm to correctly interpret the captured ECG signals.
- Palmtop computer: collects elaborated signals in suspect heart conditions and send them to the host server for accurate diagnosis.
- Host server: collects information and ECG signals from all patients, keeps track of all events and is able to redirect data to doctors and Hospitals.
Main significant achievements of the second year of the project were:
- The possibility to record the personal details, diagnosis and case history of the patient to create an information base that correlates a wide variety of elements, as well as for rapid consultation of clinical records. This would form the basis of a knowledge management system, based on datamining technology, for early diagnosis of pathologies affecting the cardiovascular apparatus.
- The system was completely automatic and did not require any technical competence from the wearer: the ideal solution for elderly people, disabled, children, etc.
- The system would have a low production cost, since the HEARTRONIC project, not only wanted to carry out research, but also exploit and adopt commercially off the shelf technologies.
- The system would meet the oncoming EU safety Law standards.
The work performed in the project was divided into seven work packages (WPs).
WP1-Preliminary requirements:
a) Specifications for the HEARTRONIC product were outlined, taking into account the different aspects: medical, electronics and telecommunications.
b) Sensor configuration was described, explaining the features and the reasons for the adoption of Frank's leads system.
c) Main pathological situation to be monitored were defined, along with the related alarm system.
d) Electronics of the system was sketched, with the selection of the most suitable components, taking into account patient's comfort, product dimensioning in terms of weight and shape, and taking care of low energy consumption.
e) Finally, the telecommunication architecture was outlined, with the choice of Bluetooth protocol for transmitting data from the wearable unit to the palmtop and GPRS for transferring data from the PDA to the remote host server.
f) Medical, electronic and TLC requirements were integrated, their mutual consistency was verified and a consolidated data sheet detailing the full description of the system form users' perspectives was produced.
WP2-ECG sensors development
This WP included the following:
a) A feasibility of ECG sensors embedded into textile fibres was examined, aiming to integrate both the wires and the sensors in the T-Shirt fabric.
b) The most suitable ECG sensors to be integrated in the T-shirt where selected and purchased, aiming reduce as much as possible the use of gel or adhesive between sensors and skin.
c) The conclusion of the studies conducted in this WP led to focus the research in improving electrode preparation techniques and better understanding of the sources of artifact, which could turn in enhancing equipment performance, resulting in improved patient conditions and signal monitoring.
d) On this basis, a set of experiments were carried out in order to evaluate the ECG sensors performances with and without adhesive, assessing both the Signal to Noise ratio of the acquired data and the patient comfort.
WP3-Electronic system design
This WP included the following:
a) All the electronic architecture of the HEARTRONIC system, including energy supply and wireless communication via Bluetooth with the PDA was designed and implemented.
b) DSP firmware for ECG signal analysis was programmed, starting from Matlab code, passing through Simulink model and finally implemented in C code.
c) Designs and electric schemes necessary to manufacture the alpha prototype were produced, along with several versions of the Printed Circuit Board.
WP4-ECG pattern recognition
a) Algorithms for digital filtering and statistical classification of ECG patterns were defined and developed in Matlab code.
b) Matlab algorithms were converted first in Simulink blocks and then in C code.
c) These algorithms were implemented into a full potential version on PC and in a light version for the on board firmware.
d) Translated algorithms were tested to verify the correspondence between the original version and the Simulink model.
e) Finally, the possibility to optimise the algorithms both in terms of computational requirements for the processor and memory usage was examined.
WP5-TLC integration
a) The objective achieved was to provide reliable and efficient communication between the Heartronic device and a cellular phone, as well as data transfer between the cellular phone and a host station, and from the host station to cardiologist's cellular phone.
b) The PC based host server for data tracking and warning management was thoroughly developed.
c) The graphic user interface for the PDA was designed, in order to provide the doctors with an easy to use graphic tool to handle the received ECG tracks.
WP6-Prototyping and testing
The testing campaign was focused on:
- Tests on the acquisition unit, assessing the performances of the sensors both with and without conducting gel.
- Tests on the algorithms, focused on the performance comparison between original Matlab algorithms and Simulink model.
- Tests on the PDA software and on the graphic interface.
- Tests on the Host server and alarm management system.
Tests on the telecommunication architecture.
WP7-Exploitation and dissemination
This final WP included the following:
a) Exploitation strategy was defined.
b) The dissemination measures carried out in the second year of the project include.
The major advantage of the HEARTRONIC system was direct multiple-lead ST segment analysis without need of approximation of the standard 12-lead ECG. Most of the ischemic events (ST elevation or depression) could be detected using the standard 12-lead ECG without addition of the posterior leads. However, it was important to have right ventricle and posterior leads for right ventricle and posterior wall-related ischemia.
The Frank leads system (8 electrodes) was used in Sweden for hospital monitoring of patients with acute coronary syndrome. The system made use of vectorocardiographic parameters in detection of ST segment changes.
The HEARTRONIC system was composed by:
- Data Acquisition Unit: reads signals from the chest and performs the first diagnosis inside the elaboration unit, composed by a high-end DSP. The digital MEMS accelerometer/inclinometer helps the ECG pattern recognition algorithm to correctly interpret the captured ECG signals.
- Palmtop computer: collects elaborated signals in suspect heart conditions and send them to the host server for accurate diagnosis.
- Host server: collects information and ECG signals from all patients, keeps track of all events and is able to redirect data to doctors and Hospitals.
Main significant achievements of the second year of the project were:
- The possibility to record the personal details, diagnosis and case history of the patient to create an information base that correlates a wide variety of elements, as well as for rapid consultation of clinical records. This would form the basis of a knowledge management system, based on datamining technology, for early diagnosis of pathologies affecting the cardiovascular apparatus.
- The system was completely automatic and did not require any technical competence from the wearer: the ideal solution for elderly people, disabled, children, etc.
- The system would have a low production cost, since the HEARTRONIC project, not only wanted to carry out research, but also exploit and adopt commercially off the shelf technologies.
- The system would meet the oncoming EU safety Law standards.
The work performed in the project was divided into seven work packages (WPs).
WP1-Preliminary requirements:
a) Specifications for the HEARTRONIC product were outlined, taking into account the different aspects: medical, electronics and telecommunications.
b) Sensor configuration was described, explaining the features and the reasons for the adoption of Frank's leads system.
c) Main pathological situation to be monitored were defined, along with the related alarm system.
d) Electronics of the system was sketched, with the selection of the most suitable components, taking into account patient's comfort, product dimensioning in terms of weight and shape, and taking care of low energy consumption.
e) Finally, the telecommunication architecture was outlined, with the choice of Bluetooth protocol for transmitting data from the wearable unit to the palmtop and GPRS for transferring data from the PDA to the remote host server.
f) Medical, electronic and TLC requirements were integrated, their mutual consistency was verified and a consolidated data sheet detailing the full description of the system form users' perspectives was produced.
WP2-ECG sensors development
This WP included the following:
a) A feasibility of ECG sensors embedded into textile fibres was examined, aiming to integrate both the wires and the sensors in the T-Shirt fabric.
b) The most suitable ECG sensors to be integrated in the T-shirt where selected and purchased, aiming reduce as much as possible the use of gel or adhesive between sensors and skin.
c) The conclusion of the studies conducted in this WP led to focus the research in improving electrode preparation techniques and better understanding of the sources of artifact, which could turn in enhancing equipment performance, resulting in improved patient conditions and signal monitoring.
d) On this basis, a set of experiments were carried out in order to evaluate the ECG sensors performances with and without adhesive, assessing both the Signal to Noise ratio of the acquired data and the patient comfort.
WP3-Electronic system design
This WP included the following:
a) All the electronic architecture of the HEARTRONIC system, including energy supply and wireless communication via Bluetooth with the PDA was designed and implemented.
b) DSP firmware for ECG signal analysis was programmed, starting from Matlab code, passing through Simulink model and finally implemented in C code.
c) Designs and electric schemes necessary to manufacture the alpha prototype were produced, along with several versions of the Printed Circuit Board.
WP4-ECG pattern recognition
a) Algorithms for digital filtering and statistical classification of ECG patterns were defined and developed in Matlab code.
b) Matlab algorithms were converted first in Simulink blocks and then in C code.
c) These algorithms were implemented into a full potential version on PC and in a light version for the on board firmware.
d) Translated algorithms were tested to verify the correspondence between the original version and the Simulink model.
e) Finally, the possibility to optimise the algorithms both in terms of computational requirements for the processor and memory usage was examined.
WP5-TLC integration
a) The objective achieved was to provide reliable and efficient communication between the Heartronic device and a cellular phone, as well as data transfer between the cellular phone and a host station, and from the host station to cardiologist's cellular phone.
b) The PC based host server for data tracking and warning management was thoroughly developed.
c) The graphic user interface for the PDA was designed, in order to provide the doctors with an easy to use graphic tool to handle the received ECG tracks.
WP6-Prototyping and testing
The testing campaign was focused on:
- Tests on the acquisition unit, assessing the performances of the sensors both with and without conducting gel.
- Tests on the algorithms, focused on the performance comparison between original Matlab algorithms and Simulink model.
- Tests on the PDA software and on the graphic interface.
- Tests on the Host server and alarm management system.
Tests on the telecommunication architecture.
WP7-Exploitation and dissemination
This final WP included the following:
a) Exploitation strategy was defined.
b) The dissemination measures carried out in the second year of the project include.
The major advantage of the HEARTRONIC system was direct multiple-lead ST segment analysis without need of approximation of the standard 12-lead ECG. Most of the ischemic events (ST elevation or depression) could be detected using the standard 12-lead ECG without addition of the posterior leads. However, it was important to have right ventricle and posterior leads for right ventricle and posterior wall-related ischemia.
The Frank leads system (8 electrodes) was used in Sweden for hospital monitoring of patients with acute coronary syndrome. The system made use of vectorocardiographic parameters in detection of ST segment changes.
