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BiomarCaRE: rationale and design of the European BiomarCaRE project including 300,000 participants from 13 European countries.

Zeller T, Hughes M, Tuovinen T, Schillert A, Conrads-Frank A, Ruijter Hd, Schnabel RB, Kee F, Salomaa V, Siebert U, Thorand B, Ziegler A, Breek H, Pasterkamp G, Kuulasmaa K, Koenig W, Blankenberg S - Eur. J. Epidemiol. (2014)

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Clinic for General and Interventional Cardiology, University Heart Centre Hamburg, Martinistr. 52, 20246, Hamburg, Germany, t.zeller@uke.de.

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.

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Related in: MedlinePlus

BiomarCaRE multi-modular concept. From biomarker selection and assay development (Module 1) to biomarker measurements and statistical analyses (Module 2) to clinical translation and economic assessment (Module 3). Module 1: Established and emerging biomarkers are prioritised according to their association with CVD risk, novel biomarkers are selected based on pre-existing non-publically available-omics datasets. Assay development is guided by SMEs and optimised for medium to high-throughput measurement. Module 2: The predictive value of biomarkers is assessed separately in population and disease based cohorts in a two phase approach; phase I assessment and phase II validation. Module 3 assesses the clinical utilisation of BiomarCaRE risk panels in clinical trials for their interaction with risk lowering therapy and develops a decision-analytical model to estimate long term cost-effectiveness of a primary or secondary preventive strategy guided by biomarker testing
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Fig2: BiomarCaRE multi-modular concept. From biomarker selection and assay development (Module 1) to biomarker measurements and statistical analyses (Module 2) to clinical translation and economic assessment (Module 3). Module 1: Established and emerging biomarkers are prioritised according to their association with CVD risk, novel biomarkers are selected based on pre-existing non-publically available-omics datasets. Assay development is guided by SMEs and optimised for medium to high-throughput measurement. Module 2: The predictive value of biomarkers is assessed separately in population and disease based cohorts in a two phase approach; phase I assessment and phase II validation. Module 3 assesses the clinical utilisation of BiomarCaRE risk panels in clinical trials for their interaction with risk lowering therapy and develops a decision-analytical model to estimate long term cost-effectiveness of a primary or secondary preventive strategy guided by biomarker testing

Mentions: 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 large-scale studies and (4) biomarker determination, analyses and validation (Module 2), and (5) biomarker assessment in clinical trials and (6) economic evaluation (Module 3). The main disease endpoints assessed in BiomarCaRE are incident acute coronary events, stroke, heart failure, atrial fibrillation, and diabetes mellitus. Other cardiovascular endpoints such as venous thrombosis will also be studied. Figure 2 gives a detailed overview about the multi-modular BiomarCaRE design.Fig. 2


BiomarCaRE: rationale and design of the European BiomarCaRE project including 300,000 participants from 13 European countries.

Zeller T, Hughes M, Tuovinen T, Schillert A, Conrads-Frank A, Ruijter Hd, Schnabel RB, Kee F, Salomaa V, Siebert U, Thorand B, Ziegler A, Breek H, Pasterkamp G, Kuulasmaa K, Koenig W, Blankenberg S - Eur. J. Epidemiol. (2014)

BiomarCaRE multi-modular concept. From biomarker selection and assay development (Module 1) to biomarker measurements and statistical analyses (Module 2) to clinical translation and economic assessment (Module 3). Module 1: Established and emerging biomarkers are prioritised according to their association with CVD risk, novel biomarkers are selected based on pre-existing non-publically available-omics datasets. Assay development is guided by SMEs and optimised for medium to high-throughput measurement. Module 2: The predictive value of biomarkers is assessed separately in population and disease based cohorts in a two phase approach; phase I assessment and phase II validation. Module 3 assesses the clinical utilisation of BiomarCaRE risk panels in clinical trials for their interaction with risk lowering therapy and develops a decision-analytical model to estimate long term cost-effectiveness of a primary or secondary preventive strategy guided by biomarker testing
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4197377&req=5

Fig2: BiomarCaRE multi-modular concept. From biomarker selection and assay development (Module 1) to biomarker measurements and statistical analyses (Module 2) to clinical translation and economic assessment (Module 3). Module 1: Established and emerging biomarkers are prioritised according to their association with CVD risk, novel biomarkers are selected based on pre-existing non-publically available-omics datasets. Assay development is guided by SMEs and optimised for medium to high-throughput measurement. Module 2: The predictive value of biomarkers is assessed separately in population and disease based cohorts in a two phase approach; phase I assessment and phase II validation. Module 3 assesses the clinical utilisation of BiomarCaRE risk panels in clinical trials for their interaction with risk lowering therapy and develops a decision-analytical model to estimate long term cost-effectiveness of a primary or secondary preventive strategy guided by biomarker testing
Mentions: 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 large-scale studies and (4) biomarker determination, analyses and validation (Module 2), and (5) biomarker assessment in clinical trials and (6) economic evaluation (Module 3). The main disease endpoints assessed in BiomarCaRE are incident acute coronary events, stroke, heart failure, atrial fibrillation, and diabetes mellitus. Other cardiovascular endpoints such as venous thrombosis will also be studied. Figure 2 gives a detailed overview about the multi-modular BiomarCaRE design.Fig. 2

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Clinic for General and Interventional Cardiology, University Heart Centre Hamburg, Martinistr. 52, 20246, Hamburg, Germany, t.zeller@uke.de.

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.

Show MeSH
Related in: MedlinePlus