Periodic Reporting for period 3 - EURO SHOCK (Testing the value of a novel strategic approach and its cost efficacy to improve the poor outcomes in Cardiogenic Shock)
Período documentado: 2021-01-01 hasta 2022-06-30
EURO SHOCK was conceived as the first large-scale clinical study testing extracorporeal membrane oxygenation (ECMO), a novel intervention strategy aimed at reducing the high mortality associated with CGS and alleviating the associated burden of chronic heart failure. The appropriately powered randomised clinical trial at the centre of the project was designed to assess whether the very early use of ECMO in the acute phase of CGS, supplementing primary percutaneous coronary intervention (PCI) and standard pharmaco-therapies, can stop the cycle of decline in patients and reduce cardiac mortality compared to the current standard of therapy alone. The project also planned to test if a system of urgent transfer of unwell patients to specialist ECMO centres is practical, and whether there are markers that predict worse outcomes when selecting patients for best-expedited treatments. The use of Cardiac Magnetic Imaging is an important mechanistic sub-study. EURO SHOCK further aimed to compare the cost-effectiveness of up-front ECMO to the cost of current standard care- such a cost-efficacy analysis will be central to any assessment of any benefit versus the price of any benefit (if) seen.
At the time of suspension, there were 19 active recruiting sites in 8 countries. In total 35 participants have been recruited and data has been collected as planned using an electronic CRF which is managed by our collaborators in the Glasgow Clinical Trials Unit. The governance infrastructure for the programme is in place, including the Trial Steering Committee, the Independent Data Safety Monitoring Committee and Clinical Events Committee. Robust monitoring of patient data is supported by the experienced Cardiovascular European Research Centre (CERC).
To raise awareness for the EURO SHOCK project, the consortium has created a website (www.euroshock-study.eu) tailored to different audiences (scientists, patients, public). The website is regularly updated and shares news with interested parties. A Multi-stakeholder Dissemination and Outreach Plan (D8.1) has been developed to ensure that dissemination and outreach activities have the highest possible impact. Outreach and dissemination activities are supported by materials created, such as a roll-up and a project factsheet. A document sharing cloud linked to the website (accelCLOUD) and mailing lists facilitate internal communication. Work on a pilot cardiac MRI study in CGS and novel approaches to remote patient monitoring is ongoing.