Periodic Reporting for period 1 - PoCCardio (Personalised Medicine by using an Advanced Point-of-Care Tool for Stratified Treatment in High Risk Cardiovascular Patients (PoCCardio))
Reporting period: 2023-12-01 to 2025-05-31
PoCCardio
(Personalised Medicine by using an Advanced Point-of-Care Tool for Stratified Treatment in High Risk Cardiovascular Patients)
Cardiovascular diseases (CVDs) are the global leading cause of death. They encompass a group of medical conditions, affecting the heart and the blood vessels, such as the arteries and capillaries, which become narrowed or even blocked due to the buildup of atherosclerotic plaques. If vessels that supply blood to the heart muscle are affected, this can result in chest pain or even a myocardial infarction, more commonly known as a heart attack. Irrespective of the fact that acute pharmaceutical and non-pharmaceutical interventions in such patients have led to an improved survival rate in the past years, still 1 out of 3 men (36%), and 1 out of 2 women (47%) will die within 5 years after surviving an initial heart attack. In other words, prevention of a subsequent heart attack has remained an unresolved challenge in clinical practice. The risk to suffer a first or subsequent myocardial infarction is determined by modifiable and non-modifiable risk factors, including smoking, obesity, diabetes, high blood cholesterol and high blood-pressure, as well as age, family history and individual genetics.
Circulating blood contains many biomolecules, which have been shown to be predictive of a myocardial infarction, and furthermore can provide information about the effectiveness of medications used to treat cardiovascular disease. These parameters include, but are not limited to, cholesterol, proteins such as the highly-sensitive C-reactive protein and genetic factors. Due to their predictive value, these biomolecules are also referred to as blood- or biochemical markers. While some of these markers can be measured routinely in healthcare institutions, others require access to highly specialized and costly laboratory equipment, which are often only located in larger institutions such as university hospitals. Subsequently, the measurement of these markers is frequently associated with considerable and unacceptable efforts for patients, not only from an organizational but also from a financial aspect.
The aim of PoCCardio is to advance and tailor a point-of-care (PoC) tool, the fundament of which was developed within the framework of a previous EU-funded project (https://pocosteo.mijnweblayout.be(opens in new window); Figure 1). Using cutting edge lab-on-a-chip (LoC) technology, these tools will now be further developed to measure qualified blood biomarkers from a fingerprick blood sample, in order to help identify, classify and monitor cardiovascular patients at high risk. For this purpose, generic electrochemical platforms for the simultaneous quantitative electrochemical detection of multiple protein and genetic biomarkers, respectively, will be developed and optimized. The clinical validation of these biomarkers and the PoC tool will then be performed in a multicenter, multinational clinical trial based on existing and approved pharmaceuticals. Dependent on the specific pattern of these qualified biomarkers, patients who had recently experienced a heart attack will be assigned either to standard pharmacological treatment, or a tailored, patient-specific intensified treatment. Data derived from this clinical trial will constitute a rich source for complex artificial intelligence powered computational analysis. The clinical value of the individual specific blood markers or a combination of them, will thus be further explored in terms of their predictive and treatment monitoring potential. The trial will also provide the scientific foundation to support regulatory authorities with regards to an approval of a combination of blood markers that will serve as so-called companion diagnostics. Finally, results of this trial will provide sound scientific evidence for the efficacy of a combination of specific drugs to prevent a subsequent heart attack. Overall, it can be expected that PoCCardio will have an enormous impact on the future care of patients who suffer from CVD and who have already experienced a heart attack. To achieve these aims, a well-balanced consortium of six academic research partners and two SMEs has been brought together.
(Personalised Medicine by using an Advanced Point-of-Care Tool for Stratified Treatment in High Risk Cardiovascular Patients)
Cardiovascular diseases (CVDs) are the global leading cause of death. They encompass a group of medical conditions, affecting the heart and the blood vessels, such as the arteries and capillaries, which become narrowed or even blocked due to the buildup of atherosclerotic plaques. If vessels that supply blood to the heart muscle are affected, this can result in chest pain or even a myocardial infarction, more commonly known as a heart attack. Irrespective of the fact that acute pharmaceutical and non-pharmaceutical interventions in such patients have led to an improved survival rate in the past years, still 1 out of 3 men (36%), and 1 out of 2 women (47%) will die within 5 years after surviving an initial heart attack. In other words, prevention of a subsequent heart attack has remained an unresolved challenge in clinical practice. The risk to suffer a first or subsequent myocardial infarction is determined by modifiable and non-modifiable risk factors, including smoking, obesity, diabetes, high blood cholesterol and high blood-pressure, as well as age, family history and individual genetics.
Circulating blood contains many biomolecules, which have been shown to be predictive of a myocardial infarction, and furthermore can provide information about the effectiveness of medications used to treat cardiovascular disease. These parameters include, but are not limited to, cholesterol, proteins such as the highly-sensitive C-reactive protein and genetic factors. Due to their predictive value, these biomolecules are also referred to as blood- or biochemical markers. While some of these markers can be measured routinely in healthcare institutions, others require access to highly specialized and costly laboratory equipment, which are often only located in larger institutions such as university hospitals. Subsequently, the measurement of these markers is frequently associated with considerable and unacceptable efforts for patients, not only from an organizational but also from a financial aspect.
The aim of PoCCardio is to advance and tailor a point-of-care (PoC) tool, the fundament of which was developed within the framework of a previous EU-funded project (https://pocosteo.mijnweblayout.be(opens in new window); Figure 1). Using cutting edge lab-on-a-chip (LoC) technology, these tools will now be further developed to measure qualified blood biomarkers from a fingerprick blood sample, in order to help identify, classify and monitor cardiovascular patients at high risk. For this purpose, generic electrochemical platforms for the simultaneous quantitative electrochemical detection of multiple protein and genetic biomarkers, respectively, will be developed and optimized. The clinical validation of these biomarkers and the PoC tool will then be performed in a multicenter, multinational clinical trial based on existing and approved pharmaceuticals. Dependent on the specific pattern of these qualified biomarkers, patients who had recently experienced a heart attack will be assigned either to standard pharmacological treatment, or a tailored, patient-specific intensified treatment. Data derived from this clinical trial will constitute a rich source for complex artificial intelligence powered computational analysis. The clinical value of the individual specific blood markers or a combination of them, will thus be further explored in terms of their predictive and treatment monitoring potential. The trial will also provide the scientific foundation to support regulatory authorities with regards to an approval of a combination of blood markers that will serve as so-called companion diagnostics. Finally, results of this trial will provide sound scientific evidence for the efficacy of a combination of specific drugs to prevent a subsequent heart attack. Overall, it can be expected that PoCCardio will have an enormous impact on the future care of patients who suffer from CVD and who have already experienced a heart attack. To achieve these aims, a well-balanced consortium of six academic research partners and two SMEs has been brought together.
The PoCCardio project aims to: (1) identify patients at extremely high cardiovascular risk after MI by using a highly relevant biomarker panel during a multicenter, multinational clinical trial; (2) further investigate whether a multi factorial, intensified treatment as compared to standard treatment has the potential to lower cardiovascular risk and recurrent events; (3) follow a companion diagnostic approach where a PoC device will be developed and validated against routine laboratory biomarker measurement.
In the first period of the project, the multicenter, clinical trial (BioRiskEvent) has received regulatory approval, according to the rules set out in the Clinical Trials Regulation EU No 536/2014. Participating study centres are distributed throughout Austria, Germany and Poland. The patient recruitment process has started recently at the Austrian Study centre in Graz. The electrochemical platforms for simultaneous measurement of the proteomic and genomic markers and the PoC device are currently in the development phase making considerable progress. In addition, the project’s excellence was considerably widened by the addition of a new academic partner within the framework of the HORIZON-WIDERA-2023-ACCESS-06 call (Hop-on facility): The Bioinformatics Department at The Cyprus Institute of Neurology and Genetics (CING), specifically the CING Bioinformatics Department (C-BIG) will support the biomarker and data analytics towards a refined diagnostic and prognostic signature for cardiovascular disease in the field of System Bioinformatics.
In the first period of the project, the multicenter, clinical trial (BioRiskEvent) has received regulatory approval, according to the rules set out in the Clinical Trials Regulation EU No 536/2014. Participating study centres are distributed throughout Austria, Germany and Poland. The patient recruitment process has started recently at the Austrian Study centre in Graz. The electrochemical platforms for simultaneous measurement of the proteomic and genomic markers and the PoC device are currently in the development phase making considerable progress. In addition, the project’s excellence was considerably widened by the addition of a new academic partner within the framework of the HORIZON-WIDERA-2023-ACCESS-06 call (Hop-on facility): The Bioinformatics Department at The Cyprus Institute of Neurology and Genetics (CING), specifically the CING Bioinformatics Department (C-BIG) will support the biomarker and data analytics towards a refined diagnostic and prognostic signature for cardiovascular disease in the field of System Bioinformatics.
Current medical care and clinical trial designs often follow the approach that patients with the same diagnosis—such as myocardial infarction (MI)—share the same underlying pathophysiology and will respond similarly to identical treatments. It is not sufficiently taken into account that different inflammatory status, cardiac function, various CV risk factors and genetic background significantly modulate the risk for future recurrent cardiovascular (CV) events (Leopold JA et al., https://pubmed.ncbi.nlm.nih.gov/29700074/(opens in new window)).
The PoCCardio project aims to provide a personalized Companion Diagnostic approach with an innovative panel of biomarkers and a risk stratification strategy in order to identify patients at very high vascular risk after MI and to explore the potential of multifactorial intensified risk factor treatment compared to standard guideline treatment recommendations. It can be expected that PoCCardio provides the foundation for improved CVD prevention and therapy monitoring for better patient outcomes and to support the relevant regulatory authorities and relevant guidelines with evidence supporting companion diagnostics in managing CVD.
The PoCCardio project aims to provide a personalized Companion Diagnostic approach with an innovative panel of biomarkers and a risk stratification strategy in order to identify patients at very high vascular risk after MI and to explore the potential of multifactorial intensified risk factor treatment compared to standard guideline treatment recommendations. It can be expected that PoCCardio provides the foundation for improved CVD prevention and therapy monitoring for better patient outcomes and to support the relevant regulatory authorities and relevant guidelines with evidence supporting companion diagnostics in managing CVD.