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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - EURO SHOCK (Testing the value of a novel strategic approach and its cost efficacy to improve the poor outcomes in Cardiogenic Shock)

Teaser

Summary

Cardio-vascular disease is a major cause of death, with 160/100 000 casualty caused by ischaemic heart disease alone in an EU census in 2016. It also carries a significant burden of morbidity and social adverse impact. This makes it one of the biggest threats to public health in Europe, with > 4 million people suffering mortality due to heart failure each year. One condition with a major mortality and morbidity is Cardiogenic Shock (CGS). CGS is the consequence of a patient suffering a large heart attack that extensively damages the heart muscle function, often beyond recovery with current therapies. 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 the mortality. It is estimated that more than 50,000 people are diagnosed with CGS each year. In addition to the high mortality there is a major impact on morbidity at a cost the European economy â‚¬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 hypothetically sound treatments or procedures that could alter the poor prognosis - current interventions show little impact on outcomes.

EURO SHOCK is the first large-scale clinical study testing a novel intervention strategy aimed at assessing this strategy to reduce the high mortality associated with CGS and alleviating its burden of chronic heart failure. The appropriately powered randomized clinical trial at the centre of the project will assess whether the very early use of extracorporeal membrane oxygenation (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 will also test, if a system of urgent flagged transfer of unwell patients is practical, and whether there are markers that predict worse outcomes, to be considered when selecting patients for best-expedited treatments. The use of Cardiac Magnetic Imaging will be an important mechanistic sub-study. EURO SHOCK will further 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.

Work performed

During the first 18 months of the project, the consortium has focused on preparing the clinical trial at the centre of the project. We have trial tracked and there was a large but differently focussed trial on CGS published in 2018. The results of this trial has allowed us to ensure that EURO SHOCK is contemporary and relevant, especially in terms of timing of primary end point. The contracts between the trial sponsor and the recruitment hubs has been prepared and is in the final stages of being signed. Establishing legal contracts between the UK Sponsor and individual Consortium members with their individual European ethical and legal country requirements was always going to be a challenging. The consortium has developed the Study protocol which has been accepted by the trial sponsor (University of Leicester) and passed through the UK national Ethics Committee and those in Latvia, Spain and Norway. It is the process of going through the German National Ethics Committee and following requested changes will shortly go through those in Belgium and Italy. All trial committees in accordance with appropriate and robust research governance requirements, have been established accordingly.
For the successful collection of high-quality data essential for interpretable results from the trial, significant input from the Glasgow CTU, collaborating with all other stakeholders has been established. Processes for the development of a user-friendly, easily interrogated electronic case report form (eCRF) has now been created. Robust monitoring of patient data is mandatory. To enable this, we were delighted to secure the experience of the Cardiovascular European Research Centre (CERC) who have now joined the EURO SHOCK consortium to support the monitoring of the trial. The first EURO SHOCK recruitment sites have already been initiated and are ready to start patient recruitment.
To raise awareness for the EURO SHOCK project, the consortium has created a website (www.euroshock-study) 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.
The CI Professor Gershlick is frequently asked to attend conferences and discuss the EURO SHOCK Trial.
A project handbook covering the coordination, contracts, finances, reporting and communication functions as the first â€œgo-toâ€ document for management related questions within the consortium. The partners have also signed a consortium agreement.

Final results

Cardiogenic shock results in poor quality of life with frequent hospital admissions, dependence on carers and potential loss of employment. EURO SHOCK aims 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. EURO SHOCK results will be applicable world-wide and lesions and understanding attained irrespective of trial outcomes. The project particularly focuses on vulnerable subgroups such as the elderly and females, as well as patients with multi-morbidities. The study results will be used to contribute to standards, guidelines and clinical practices for treatment of cardiogenic shock patients. The outcomes will have an economic impacts, including the reduction of the excessive healthcare costs associated with cardiogenic shock (life-long care support, need for expensive implantable devices and use of multiple, expensive drugs). EURO SHOCK will also have an impact on the job market, leading to more healthcare professionals being employed at the high-intensity end of the care spectrum.