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Implementation of personalised risk prediction and prevention of sudden cardiac death after myocardial infarction

Project description

New device prevents sudden cardiac death

Sudden cardiac death (SCD) represents a major public health concern since it is responsible for about 20 % of all deaths in Europe. It affects mostly patients with myocardial infarction (MI) precedents. SCD can be prevented with the implantable cardioverter-defibrillator (ICD) device. However, it is costly and associated with potentially serious complications. The ICD is recommended as a prophylactic solution for post-MI patients, but only a few of them receive the device, while the majority of implantations are directed to patients without a medical recommendation for it. The EU-funded PROFID project will use clinical datasets and advanced technology to develop a clinical decision support instrument that will predict the individual SCD risk and identify post-MI patients suitable for an ICD device.

Objective

Sudden cardiac death (SCD) is a major public health problem accounting for ~20% of all deaths in Europe with
an estimated yearly incidence of ~350-700,000, often in patients with previous myocardial infarction (MI). In
SCD, the heart suddenly and unexpectedly stops beating. If untreated, the patient dies within minutes, but SCD
can be successfully prevented by an implantable cardioverter-defibrillator (ICD). The ICD is highly effective,
but is associated with potentially severe complications and high healthcare costs. Based on historical evidence,
guidelines recommend prophylactic ICD implantation in post-MI patients with left ventricular ejection fraction
(LVEF)≤35% to prevent SCD. However, only a minority of these patients will ever need the device. In addition, in
absolute numbers the majority of SCD cases occurs in patients with LVEF>35% who are currently not considered
for prophylactic ICD. Due to the inherent risks and considerable health care expenditures, a personalised treatment
approach for ICD implantation is urgently required. Using state-of-the-art methods and large clinical datasets from
established international cohorts and registries across different European geographies, PROFID will develop a clinical
decision support tool (risk score) to predict the individual SCD risk and identify those post-MI patients that will
optimally benefit from an ICD. Two parallel randomised clinical trials will validate implementation of the risk score to
determine ICD implantation, while health economic analyses will assess its economic impact on health care systems.
A software tool for clinical use of the risk score will be implemented, and a pilot run in 3 European regions with
participation of insurance companies and authorities. The unique composition of the consortium with key opinion
leaders, patient organisations, large hospital chains, payers, policy makers and state authorities across Europe, will
ensure implementation into routine clinical practice.

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Programme(s)

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IA - Innovation action

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Call for proposal

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(opens in new window) H2020-SC1-BHC-2018-2020

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Coordinator

CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 6 029 392,79
Address
Chariteplatz 1
10117 Berlin
Germany

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Region
Berlin Berlin Berlin
Activity type
Higher or Secondary Education Establishments
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 6 029 392,79

Participants (25)

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