Clinical validation

The validation study will be performed jointly by the Medical University of Graz in Austria and the Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences in Iran. Based on the voluntary participation of 60 randomly selected adult patients who fulfil the inclusion criteria, blood samples will be collected and used for multiple measurement tests.

The validation study will allow the project to evaluate the sensitivity, specificity, turnaround time and robustness of the PoC device in assessing the targeted proteomic and genomic biomarkers and polymorphisms in comparison with current state-of‐the‐art. The validation of PoC device is thus a crucial step before it can be used in the field for the multi-national clinical trial.

The clinical trial is a prospective, randomized, controlled, open-label, parallel group multicentre trial with an add-on observational cohort study. A total of 1836 patients with recent myocardial infarction (MI) will be invited to participate where 1536 patients will be included in the randomised, controlled trial and 300 patients will participate in the observational cohort study.

The primary objective is to investigate whether an intensified, multifactorial risk factor management, guided by selected biomarkers measured by the PoC device can reduce the risk for a composite cardiovascular (CV) outcome, encompassing CV death, non-fatal MI, non-fatal stroke and hospitalisation for coronary revascularisation and hospitalisations for heart failure in patients with recent MI. The trial will also assess whether the PoC device is a suitable and reliable tool to assess the selected biomarker panel in patients after acute MI.

In selected sites, the PoCCardio tool will be used together with routine clinical laboratory for the measurement of biomarkers. In the remaining clinical sites, the biomarker measurements will only be performed in the routine clinical laboratory.