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

Original description

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.

Status

SIGNED

Url

https://cordis.europa.eu/project/id/847999

Call topic

SC1-BHC-25-2019

Update Date

26-10-2022