Cohort profile: 'Biomarkers of Personalised Medicine' (BioPersMed): a single-centre prospective observational cohort study in Graz/Austria to evaluate novel biomarkers in cardiovascular and metabolic diseases

Abstract

Purpose: Accumulating evidence points towards a close relationship between cardiovascular, endocrine and metabolic diseases. The BioPersMed Study (Biomarkers of Personalised Medicine) is a single-centre prospective observational cohort study with repetitive examination of participants in 2-year intervals. The aim is to evaluate the predictive impact of various traditional and novel biomarkers of cardiovascular, endocrine and metabolic pathways in asymptomatic individuals at risk for cardiovascular and/or metabolic disease.

Participants: Between 2010 and 2016, we recruited 1022 regional individuals into the study. Subjects aged 45 years or older presenting with at least one traditional cardiovascular risk factor or manifest type 2 diabetes mellitus (T2DM) were enrolled. The mean age of the participants was 57±8 years, 55% were female, 18% had T2DM, 33% suffered from arterial hypertension, 15% were smokers, 42% had hyperlipidaemia, and only 26% were at low cardiovascular risk according to the Framingham 'Systematic COronary Risk Evaluation'.

Findings to date: Study procedures during screening and follow-up visits included a physical examination and comprehensive cardiovascular, endocrine, metabolic, ocular and laboratory workup with biobanking of blood and urine samples. The variety of assessed biomarkers allows a full phenotyping of individuals at cardiovascular and metabolic risk. Preliminary data from the cohort and relevant biomarker analyses were already used as control population for genomic studies in local and international research cooperation.

Future plans: Participants will undergo comprehensive cardiovascular, endocrine and metabolic examinations for the next decades and clinical outcomes will be adjudicated prospectively.

Keywords: Cardiac Epidemiology; General diabetes; General endocrinology.

Figure 1

Illustration of the comprehensive phenotyping and biosampling of the BioPersMed cohort. Follow-up visits are performed according to a tight preplanned schedule, including reminder-phone calls by study nurses with phenotyping and biosampling every second year and a follow-up telephone visit in the years between. At baseline, every participant received a patient’s diary for documentation of medical events (source data). CV, cardiovascular; T2DM, type 2 diabetes mellitus.

Figure 2

The recruitment status over time and the follow-up of the participants’ phenotyping in the BioPersMed cohort. (A) Absolute number of participants who have completed various on-site follow-ups until first September 2021. (B) Timeline of recruitment and follow-up processes.

Figure 3

R-plot of the analysed data set. Potential biomarkers are not grouped; instead, random clusters of correlations are formed. blue zones indicate positive correlations, red zones indicate negative correlations. As an example, zones of strong correlations are zoomed and potential biomarkers are depicted.