Abstract
Biomarkers are considered as tools to enhance cardiovascular risk estimation. However, the value of biomarkers on risk estimation beyond European risk scores, their comparative impact among different European regions and their role towards personalised medicine remains uncertain. Biomarker for Cardiovascular Risk Assessment in Europe (BiomarCaRE) is an European collaborative research project with the primary objective to assess the value of established and emerging biomarkers for cardiovascular risk prediction. BiomarCaRE integrates clinical and epidemiological biomarker research and commercial enterprises throughout Europe to combine innovation in biomarker discovery for cardiovascular disease prediction with consecutive validation of biomarker effectiveness in large, well-defined primary and secondary prevention cohorts including over 300,000 participants from 13 European countries. Results from this study will contribute to improved cardiovascular risk prediction across different European populations. The present publication describes the rationale and design of the BiomarCaRE project.Electronic supplementary materialThe online version of this article (doi:10.1007/s10654-014-9952-x) contains supplementary material, which is available to authorized users.
Highlights
Despite significant advances in treatment, cardiovascular disease (CVD) remains the leading cause of death worldwide
The BiomarCaRE project is designed as a multi-modular study including: (1) biomarker selection based on omics discovery studies as well as literature, and (2) assay development (Module 1), (3) data harmonization of largescale studies and (4) biomarker determination, analyses and validation (Module 2), and (5) biomarker assessment in clinical trials and (6) economic evaluation (Module 3)
Selected biomarkers from phase 2 will be measured in samples of clinical trials to test their interaction with risk lowering therapy (Table 5) and a decision-analytic model will be developed to estimate long-term effectiveness and cost-effectiveness of a primary or secondary preventive strategy based on additional risk assessment using these biomarkers
Summary
Despite significant advances in treatment, cardiovascular disease (CVD) remains the leading cause of death worldwide. The consortium capitalizes on in depth knowledge of omics-based candidate markers and integrates modern technologies of multiple biomarker assessment It comprises 21 well-established prospective European population-based cohort studies, most of which were previously harmonized in the MORGAM Project [9], four cohorts of diseased subjects (disease cohorts, secondary prevention) and four clinical trials, totalling over 300,000 participants with a follow-up of over three million person years and storage of selected biomaterial of all participants in one central BiomaCaRE laboratory (University Heart Center Hamburg). This large individual-based database provides a unique opportunity to investigate the performance of established and novel biomarkers for Cardiovascular Risk Assessment across Europe. The consortium comprises an established research governance infrastructure, data harmonization and sharing arrangements, two central secure, access-managed phenotypic and biomarker data repositories as well as a core laboratory for biomarker measurements
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