Two clinical trials
Laboratory Validation Study & Multinational Clinical Trial
Two consecutive clinical trials will be carried out in PoCCardio: A laboratory validation study and a multinational clinical trial. Both trials will adhere to the Clinical & Laboratory Standards Institute (CLSI) guidelines and the In Vitro Diagnostic Regulation 2017/746 (IVDR). The trial results will be reported according to the CONSORT standards.
POCT-Cardio-Val trial
Following the fabrication of the PoCCardio Point-of-Care (PoC) instrument, a laboratory-based validation study will be conducted to assess whether the instrument can support the evaluation of the selected target biomarkers and polymorphisms.
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 enable the project to evaluate the sensitivity, specificity, turnaround time, and robustness of the PoC instrument in assessing targeted proteomic and genomic biomarkers and polymorphisms, compared with the current state-of-the-art. The data will also provide a baseline for comparing biomarkers and genetic variability between two ethnicities.
The clinical trial is a prospective, randomised, controlled, open-label, parallel group multicentre trial with an add-on observational cohort study. A total of 1758 patients with recent myocardial infarction (MI) will be invited to participate. Of these, 1458 patients will be enrolled in the randomised, controlled trial, while 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 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 hospitalisation for heart failure in patients with recent MI.
The trial will also assess how well the PoC instrument can be integrated into routine clinical workflows in a real-world clinical setting. Furthermore, the usability of the instrument will be explored to evaluate the interaction between users and the device under real-world clinical conditions.
BIO-RISK-EVENT trial
The PoCCardio multinational clinical trial will be conducted across clinical centres in Austria, Germany and Poland. The trial aims to evaluate the effectiveness of intensified residual risk management compared with standard guideline-based treatment in reducing cardiovascular events among patients with recent myocardial infarction who are at an extremely high risk of recurrent cardiovascular events. In addition, the study will assess the usability of the PoC instrument in a clinical setting.
