PoCCardio is developing an innovative point-of-care tool using disease-specific markers from finger-prick blood for fast detection of heart patients at a very high risk of further cardiovascular events. Clinical validation involves more than 1800 patients from Austria, Germany, Belgium and Poland.

“Heart attacks are a major cause of morbidity and mortality globally. And despite the availability of tools for risk stratification and a variety of drugs and treatment approaches, the incidence of recurrent cardiovascular events remains high in people with previous myocardial infarction. The aim of PoCCardio is to identify these high-risk patients to personalise and intensify their treatment and thus lower the risk”, explains Project Coordinator, Prof. Hans Peter Dimai from the Medical University of Graz.

To classify patients and enable advanced individualised risk prediction, PoCCardio uses a panel of ten qualified biological markers and six genetic variants, measured simultaneously using a point-of-care device. Blood-based biomarkers are ideal to evaluate the health status, being relatively simple and cheap to access, and they can play an important role in stratifying risk and guiding risk factor management. By using multiple disease-specific biomarkers, PoCCardio takes into account the heterogeneity related to recurrent cardiovascular events to significantly improve the prediction of these events and tailor treatment accordingly.

A major challenge to biomarker-based identification is the implementation in routine patient care. After a heart attack, most patients are managed in primary healthcare institutions, often requiring the submission of blood samples to external laboratories. These infrastructural limitations prevent the possibility of immediate adaptation of risk-factor control during a single patient visit and thus potentially delaying cardiovascular risk management and lowering patient adherence. To solve this, the PoCCardio point-of-care tool is designed as a self-contained and portable device for immediate analysis of blood samples from patients, using microfluidic technology. This enables the health personnel to rapidly determine the risk profile and provide the affected patients with personalised care in a timely, low-cost and comfortable manner.

Clinical validation in a multinational trial
After an initial laboratory validation process evaluating the performance of the tool, a clinical validation of the tool and biomarkers will take place in a multinational trial. The trial will include up to 35 clinical study centres in Austria, Germany, Belgium and Poland and around 1800 patients with recent myocardial infarction. Of these, 1500 will participate in a randomised, controlled trial and 300 will be part of an observational study. Based on their specific pattern of biomarkers, the patients will be assigned to either standard or intensified pharmacological treatment, using only approved pharmaceuticals. The validation process will also include testing the tool in an Iranian setting to detect any differences regarding risk factors, treatment response and outcome.

“The results will show whether an intervention based on biomarker-driven risk stratification and intensified, multifactorial treatment can indeed improve the outcome for people at an extremely high risk after a heart attack, compared to the current guidelines. In fact, a companion diagnostic such as the PoCCardio tool may not only result in novel treatment strategies for highly vulnerable patients and better outcomes but also help improve the general management of cardiovascular patients through facilitated risk-factor monitoring and management”, concludes Hans Peter Dimai.