Forschungs- & Entwicklungsinformationsdienst der Gemeinschaft - CORDIS


RapidEx Berichtzusammenfassung

Project ID: 666666

Periodic Reporting for period 1 - RapidEx (Validation of a point-of-care H-FABP test for a rapid exclusion of Acute Myocardial Infarction in patients with cardiac complaints.)

Reporting period: 2015-04-01 bis 2016-03-31

Summary of the context and overall objectives of the project

A €1.63M EU Horizon 2020 SME instrument grant awarded to Dutch-based start-up company FABPulous BV in 2015 has provided financing for three “work packages” to evaluate the company’s H-FABP True Rapid Test as a biomarker tool for managing chest pain patients at critical points in the patient pathway of any health care system.

What is the H-FABP True Rapid Test?
Heart type Fatty Acid Binding Protein (H-FABP) is a small, mobile, protein that carries energy to heart muscle and is detectable in higher blood levels shortly after heart muscle dies during a heart attack. H-FABP True Rapid Test provides a five-minute result from a finger prick blood test that detects the presence of H-FABP and could make it possible for doctors to reduce the number of patients discharged in error and slash the number of patients unnecessarily admitted to hospital.
Only approximately one in six patients who arrive at the emergency department (ED) complaining of chest pain are actually having, or at immediate risk of a heart attack. A majority of the remaining patients are admitted for observation and later discharged without a diagnosis of Acute Coronary Syndrome (ACS). This safeguard approach by referral and subsequent admission of chest pain patients is one of the most challenging problems in modern medicine, costing time, money and reducing available beds for other patients. At the moment doctors lack the tools to confidently discharge chest pain patients whose symptoms are inconsistent.
It is estimated that, with approximately 5 million chest pain presentations in the EU each year, about 1 million patients could be discharged without admission and meantime reducing the risk of missing a genuine heart attack.

What we are doing now?
For H-FABP True Rapid Test to be adopted for use in general medical practice, lengthy and expensive clinical trials need to be conducted to provide the necessary evidence of the patient outcome and the benefit to the healthcare services; and to confirm the utility and reliability of the test in the hands of nurses and doctors at the point of care. Additionally the test needs to be affordable and quality-assured, which requires investment in the transfer of manufacturing to the EU, close to the Dutch-based company, and in automation to increase capacity to meet demand and reduce the costs of goods.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Work Package 1: Primary Care Clinical Trial (RAPIDA).
The ‘RAPIDA’ trial (RAPid test for Investigating complaints possibly due to Acute Coronary Syndrome (ACS)), is a derivation and validation study based at the universities of Maastricht in the Netherlands and Leuven, Belgium. The objective is to investigate the use of an H-FABP test in combination with standard GP diagnostic procedures, anticipating a reduction in the 5% of ACS cases that are missed in error and reducing the 60% of referrals to cardiology for whom ACS is subsequently eliminated as a diagnosis. With approvals for the trial protocol and ethics committee already gained prior to April 2015, the steering team has concentrated on recruiting patients to participate in the trial. By March 31st 2016, 186 patients (towards a target of 600) have been included. Anticipating the need to accelerate numbers to achieve completion in 2016, the steering team engaged 3 HAPs (‘Huisartsenpost’, or GP Medical Post) that provide out-of-hours emergency service for local family doctor practices to join in the study. HAP Maastricht commenced recruiting patients in December 2015 and will be joined shortly by Brabant and Heerlen.
In preparation for the Healthcare Economic Analysis that is a deliverable from this trial, a Model Analysis of Economic Costs manuscript has been prepared and submitted for peer review publication in March 2016. This analysis concludes that the increase in GP sensitivity and specificity could result in annual cost savings to The Netherland of €11 million with 150 fewer missed cases of ACS.

Work Package 2: TSB Emergency Medicine Trial (RapidEx)
Under the title RapidEx (Rapid Exclusion of ACS), this trial has the objective to assess whether a novel point of care device for heart-type fatty acid binding protein (H-FABP) can be used to accurately rule out Acute Myocardial Infarction (AMI, or heart attack) when used alongside other clinical information as part of the Manchester Acute Coronary Syndromes (MACS) decision rule within 3 hours of arrival in an Emergency Department (ED). In a separately funded study, Dr Rick Body of Central Manchester University Hospitals NHS Foundation Trust (CMFT) started the 650 patient derivation and validation study (within the BEST Study) into the use of H-FABP True Rapid Test in the moment of need and at the point of care as part of the MACS protocol. Under the same ethics committee approvals and with a minor change to the same protocol, RapidEx will continue to recruit a further 925 patients as an external validation of the protocol. To ensure seamless crossover from derivation study to external validation, CMFT has engaged with 14 additional EDs in NHS England to ensure the study can be completed within the allotted time. During the period between April 2015 and March 2016, 494 patients were recruited towards the 650 phase 1 target. Nine (9) external sites were contracted into the study, trained and commenced recruiting patients. Five more EDs have been engaged and will commence activity in the 2nd phase. We anticipate the RapidEx phase will commence in June 2016.
The groundwork for the Healthcare Economic Study has been laid. X-Labs Ltd (Leeds, UK) has been engaged to provide a modified version of their NETIMIS software to work with an emergency medicine model which was completed in December 2015. This software will map individual patient’s progress through their unique clinical pathway and attach granular costs to each activity. In collaboration with Oxford Diagnostic Evaluation Collaborative, the Health Economic study will be conducted and reported by Dr Yaling Yang, Senior Researcher in Health Economics at the Nuffield Department of Primary Care Health Sciences of the University of Oxford.

Work Package 3: Semi-automation of the manufacturing process
Currently the prototype CE-marked H-FABP True Rapid Test is hand-manufactured through the activities of three companies in three sites across the USA and Canada. Such a process is difficult to coordinate and control and leads to increased cost of goods. Helvoet BV (Tilburg, Netherlands) has been chosen as our manufacturing partner for the finished commercial product. The hard moulds were ordered at Helvoet in June 2015 and completed on schedule November 2015. The mould designs included some changes to improve the main product performance, the assembly of the resulting parts and the ease of use of the finished product. In December 2015 the quality comparison of the resulting parts was carried out by Symbient Inc, who were responsible for the initial parts design, resulting in a minor adjustment. Transfer of the assembly know-how proved more difficult and resulted in re-engineering process and fixtures at Helvoet. Subsequently, a first batch of 1000 sampling modules and top-housing sub-assemblies was manufactured and is currently undergoing comparative evaluation. The recreation of fixturings at Helvoet has brought forward the initial steps of 2nd phase, i.e. semi-automation and this was completed in March 2016.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

These three work packages will provide the medical community with the necessary evidence to improve clinical pathway decision making wherever chest pain patients present in the healthcare system. At GPs, fewer patients will be discharged in error, improving their span and quality of life. In EDs, patients can be discharged within 4 hours of presentation with reduced risk of error, preventing 30% of current overnight observation admissions. This saves lives, saves money, conserving precious medical resources and improves the general well-being of patients and their families. The transfer of manufacturing will result in a quality assured, reliable and affordable product manufactured within the European Union.

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