Community Research and Development Information Service - CORDIS

H2020

COPCAR Report Summary

Project ID: 717805

Periodic Reporting for period 1 - COPCAR (Heart monitoring and early assistance in high risk crisis without patient intervention (COPCAR))

Reporting period: 2016-04-01 to 2016-09-30

Summary of the context and overall objectives of the project

"COPCAR consists of a system for cardiac monitoring and real-time diagnosis and direct communication with a SCC (signals collection center). It allows to decrease the patient assist time by 70% thanks to the automatic diagnostic’s agility and it’s validation by a set of specialist physicians located at the SCC. Patients can do an absolutely normal life while monitoring is underway.

The system works without any action by the patient and anywhere, as the patient will be always geographically located.

PROBLEM TO BE SOLVED AND SOCIAL IMPACT

COPCAR will help reduce death stats caused by cardiovascular diseases (in Spain, 30% of cardiovascular diseases are ischemic heart disease, representing about 50.000 deaths per year). COPCAR will also reduce unnecessary asissts and thus, to decrease the problems due to the overloaded health system and overspending.

Another benefit from the system is a beneficial sense of tranquility and permanent protection for patients and their relatives, creating the needed ecosystem for independence maintaining for longer.

Cardiovascular diseases are the leading cause of death in the world. 300 people die in Spain from cardiovascular disease each day, of which, 100 people die because of a heart attack. In 90% of cases, assistance is late, because every minute mean saving lives. In addition, people who have survived a severe cardiovascular disease, live with a high component of psychological insecurity.

Further, both public and private health systems support high query load and functional tests, which in many cases are unnecessary, assuming high hospital costs.

In this direction, the average spending on health will experience an average global growth over 4% between 2015 and 2019, according to the "global health sector Study 2016" prepared by the area of Life Sciences and Health Care of Deloitte.

In the case of COPCAR, innovation is the integration of existing technologies and, specially, the software for automatic detection of cardiovascular abnormalities developed by COPCAR (automatic diagnosis of abnormalities), which is able to alert of any cardiovascular event, including myocardial infarction, in real time and continuously, allowing the patients to do their normal life, anywhere. This software has been tested using more than 240 annotated electrocardiogram files.

The COPCAR system allows to detect risk events automatically and in real time, the evaluation of the events and actions to take, differentiating between event to take into account, urgency event and emergency event. Furthermore, the systems alerts or inform to the proper services (SCC, specialized emergency services, pre-emergency, emergency, specialists or family). The system sends only those data which, once processed in the smartphone, are capable of generating a risk episode. Thus, not all electrical activity of the heart is sent.

Through the device that the patient wears (signal collection device + garment), the system allows to control the required cardiac parameters defined by the specialist to determine the patient's condition.

The service that COPCAR offers to patients is complemented by an smartphone app to allow the patient’s family to check the cardiological status or receive alerts on detection of serious cardiovascular event from the patient.

GLOBAL GOALS

• Minimize the number of deaths from ischemic heart disease, through the monitoring of patients prone to this disease (80% of the infarcted dying due to loneliness or remoteness from instant medical care).

• Reduce unnecessary spending on health care, as the COPCAR system discovers certain anomalies or medical episodes which do not require hospital admissions (i.e.: anxiety attacks confused with heart attacks which lead to numerous hospital admissions).

• Reduce unnecessary medical visits or revisions which pose unnecessary spending for public and private health systems.

• Make available to society a novel health preventive system which save costs and time to cardiovascular patient care and its agents involved: medical, family and health system as a whole."

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Currently, COPCAR has achieved the following milestones:

• Product finished, clinically validated and in process of obtaining the CE marking, whose completion is expected in December 2016
• General registration of industrial property with numbers 08/2011/616 and 08/2012/1122.
• Granted patent with number P201431494.
• Agreement with pharmaceutical distributor (HEFAME) for storage and shipping kit to Spain.
• ISO 13485 quality management system implanted.
• License as medical devices manufacturer, issued by the Spanish Agency for Medicines and Medical Devices (AEMPS).
• Technical File and CE Mark requirements elaborated.
• Seal of Excellence awarded by the European Commission under the Horizon 2020 program.
• COPCAR has developed a comprehensive risk assessment according to the ISO 14791 standard, which includes a detailed analysis of any underlying cause that may pose a risk to the patient and a set of actions to mitigate those risks, so that every aspect is under control.
• Key innovation points:
1. Real time event detection
2. Automatic presumptive diagnostic
3. ischemic heart disease (infarction) detection (3 Lead ECG)
4. Involvement family environment maintaining autonomy and patient monitoring.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

By using the COPCAR system, the following benefits are expected:

• Improving the quality of life of patients and their families. Feeling protection and welfare.
• Avoiding unnecessary trips to hospital, which will save € 1,500 for attendance by false positive.
• Savings in functional tests unnecessary.
• Medical consultations less congested.
• Reduction of hospitalizations not justified.
• Control of patients in disadvantaged or unreached areas.
• Control of patients during rehabilitation process and secondary prevention without medical center(center cost and spaces avoidance)

The market we address has, only in Spain, a size of about 3 million users, of which 1 million suffers from ischemic heart disease (heart attack).

This diagnostic and cardiovascular treatment market, is currently controlled by holter device manufacturers, which do not automatically diagnose in real time, but in order to make a diagnosis, it require that all heart activity be recorded in offline mode, and then, once the holter session has finished, the data are reviewed and a diagnosis is issued. In addition to the feature of offline diagnostics, there is another negative point: very few solutions offer the number of ECG signals needed for detection of ischemic heart disease (heart attack), as does the sensorized textile garment used by COPCAR.

On the other hand, we find the market for cardiac monitoring for athletes, both casual and professional. Here there are many alternatives, however, they are not designed with the goal of automatic detection of cardiovascular abnormalities in real time.

In the future, COPCAR aims:

• Selecting and integrating with a technology partner that meets the medical and technical requirements for implementation of service (classification as a medical device)
• Teleconsultation as an additional optional service. Patients can call and talk to a specialist through telephone. This option includes a stay for two years.
• Services offered to cardiologists, who can manage and monitor their own patients. This line includes a mobile APP for specialists to manage and receive alarms monitoring their patients anywhere.
• Creation of a database to store data collected by the system to allow research tasks and to develop new products.
• The study of a subset of data for determination of a pattern catalog.
• Develop a system for generating predictions.
• Software Platform for interaction (administration, management and use) catalog management patterns and predictions.

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