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)
Okres sprawozdawczy: 2021-01-01 do 2022-06-30
Cardio-vascular disease (CVD) is a major cause of death, with a case fatality rate of 160/100 000 caused by ischaemic heart disease alone in an EU census in 2016, resulting in about 4 million death per year. CVD also carries a significant burden of morbidity and adverse social impact due to loss of earnings due to premature deaths and impaired quality of life in those living with CVD. This makes CVD one of the biggest threats to public health in Europe. One condition with major mortality and morbidity is Cardiogenic Shock (CGS) which can occur after a large heart attack that extensively damages the heart muscle function. Patients with cardiogenic shock have a 50% chance of dying within the first 30 days. This incidence of death has not changed in 20 years despite various small studies of therapeutic strategies designed to attenuate mortality. It is estimated that more than 50,000 people are diagnosed with CGS each year in the EU. In addition to the high mortality there is a major impact on morbidity at a cost to the European economy of about €210 billion a year. Despite high mortality rates and immense health care expenses, little quality robust research has been conducted to determine if there are potentially useful treatments or procedures that could alter the poor prognosis as current interventions show little impact on outcomes.
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.
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.
During the project, the Consortium focused on advancing the clinical trial at the centre of the project. The COVID-19 pandemic has impacted EURO SHOCK in particular as the primary therapeutic intervention (ECMO) has been extensively repurposed for the treatment of advanced COVID pneumonitis, and many of the health care professionals supporting EURO SHOCK were prioritised to the care of COVID patients. Professor Tony Gershlick, Scientific lead for EURO SHOCK, also sadly passed away from COVID in November 2020. Following this, Professors Marcus Flather and Manel Sabate took over consortium leadership responsibilities with Dr Dave Adlam as Scientific Lead. Unfortunately, the clinical trial was unable to achieve its recruitment target and this was discussed with the Consortium, Trials Steering Committee and European Commission who also requested a full review of the conduct of the study. A decision to suspend the trial was taken at the extraordinary meeting of the Trial Steering Committee/ Consortium on 26th January 2022. Following this, close-down activities were commenced in February 2022.
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.
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.
Cardiogenic shock results in poor quality of life with frequent hospital admissions, dependence on carers and potential loss of employment. The original EURO SHOCK project aimed to improve the mortality, and in those who survive, their health and quality of life for EU citizens and the global population affected by it. Due to the inability of the project to recruit the required numbers of patients, the EURO SHOCK project is unlikely to provide results that will change practice or improve outcomes. A Scientific Meeting on the management of CGS is planned in Barcelona on 2nd December with input from other groups in the field, including ECLS SHOCK and ANCHOR. A descriptive report on the main findings of the projects will be provided at the end of the study, as well as all deliverables which can be achieved with the reduced patient population enrolled. The project has established a European network of investigators managing complex myocardial infarction patients, which allows for future collaboration and potential for improvements in health care.