GlyCardial begins the clinical trial of its novel diagnostic device for myocardial ischemia
GlyCardial Diagnostics, located at the Barcelona Science Park, has announced the enrolment of the first two patients in the EDICA trial: a multicenter international clinical study for the early detection of myocardial ischaemia. The company –a spinoff of the Research Institute of the Hospital de la Santa Creu i Sant Pau (IR-HSCSP) and the Spanish National Research Council (CSIC), has developed innovative technology for the detection of Apo J-Glyc protein, as a novel biomarker in blood for the diagnosis and prognosis of myocardial ischemia, and expects to demonstrate the reliability of the new test in hospital laboratories.
The EDICA trial is a multicenter international in vitro study designed to validate the performance of Apo J-Glyc as a novel biomarker for the early detection of Myocardial Ischaemia. The validation of this novel biomarker will be an important breakthrough in the cardiovascular field, as currently there are no specific biomarkers for the early detection of ischemia. This early diagnosis will allow to identify the event when the cardiac damage is still reversible, minimizing the consequences of the disease.
Thepatients have been included at the Santa Creu i Sant Pau Hospital in Barcelona by the team headed by Dr. Alessandro Sionis and at the La Paz University Hospital in Madrid by the team headed by Dr. José Luis López-Sendón.
The company plans to enrol approximately 646 patients and in the trial that will initially involve six sites at four leading hospitals in Spain and UK. Study participation for each patient will be approximately 12 months which will allow not only to evaluate the diagnostic value of the biomarker but also its prognostic and risk-stratification added value.