(October 26th 2022) Tallaght University Hospital (TUH) celebrated Innovation Week with an announcement of a new partnership which ultimately aims to personalise treatment and optimise patient care following a Transient Ischaemic Attack (TIA) or ischaemic stroke.
The Vascular Neurology Research Team at the Dept. of Neurology & Stroke Service, TUH / Academic Unit of Neurology, School of Medicine, TCD is led by Professor Dominick McCabe, Consultant Neurologist / Clinical Professor in Neurology. Prof. McCabe (Principal Investigator and Chairperson of the Vascular Neurology Research Foundation [VNRF.ie]), and a team of national and international collaborators are working with AcquisHEALTH to develop a cloud-based solution to capture and analyse data from the landmark, multi-centre ‘Optimal Antiplatelet Therapy in TIA and Ischaemic Stroke-International (OATS-I) Study’. This clinically important work is being funded by a recently-awarded Enterprise Ireland Innovation Partnership Programme Grant.
“There is an important link between research and innovation, and the Hospital strives to be at the forefront of translational research that adds value to patient care.” TUH Research Strategy 2020 – 2024 | People Caring for People to Live Better Lives
Stroke is the 2nd leading cause of death (GBD 2016 Stroke Collaborators, 2019) and the most common cause of acquired physical disability in adults worldwide (Gorelick, 2019). All transient ischaemic attacks (TIAs) by definition and the majority (85%) of strokes (Kapila et al., 2019) are ‘ischaemic’ in origin, and are caused by reduced blood supply to the brain, eye, or spinal cord.
Platelets play a pivotal role in the formation of blood clots and are excessively activated or 'hyper-reactive' after a TIA or ischaemic stroke. Antiplatelet agents such as Aspirin, Clopidogrel, Dipyridamole or Ticagrelor, or specific combinations of these medications can reduce the risk of recurrent vascular events in patients who have had a TIA or ischaemic stroke. However, several studies by Prof McCabe’s research group and others around the world have shown that many people do not respond as expected to commonly-prescribed doses of these antiplatelet medications in the laboratory, and have ‘high on-treatment platelet reactivity’ (HTPR). The OATS-I researchers have preliminary data to suggest that HTPR may be associated with a higher risk of recurrent vascular events in the clinical setting following TIA or ischaemic stroke (Lim ST et al, 2020), but this needs to be proven in a definitive multi-centre study.
The innovative OATS-I observational study is assessing HTPR status using novel and established laboratory tests, whilst also performing individualised genetic testing in all participants following TIA/ischaemic stroke. Predictive models combining clinical, HTPR and cutting-edge pharmacogenetics data will be constructed. We aim to identify patients with TIA/ischaemic stroke who are at higher risk of experiencing recurrent vascular events (TIA, stroke, heart attacks) on their prescribed antiplatelet regimen, and who should benefit from ‘personalised antiplatelet therapy’ to optimise cost-effective secondary prevention. This is a critical step towards the conduct of a definitive trial of HTPR-tailored antiplatelet therapy in this patient population with ischaemic cerebrovascular disease (CVD).
Acquis BI has developed and released AcquisHEALTH, a cloud-based healthcare integration platform, with a dedicated clinical research study module for the OATS-I study. At its core is a secure, shared-care record (SCR), with access to the E-CRF limited to authorised, trained clinical researchers involved in the OATS-I study. With GDPR, security, and privacy in mind, AcquisHEALTH uses multi-level encryption and novel pathways to ensure data security and identity management.
AcquisHEALTH was designed based on Health Standards compliant software (HL7/FHIR) with integrated SMOMED CT and ICD-10 clinical terminology services to further minimise data input errors, to improve speed and accuracy of data entry, facilitate analysis, and systems inter-operability.
The AcquisHEALTH clinical study/trials Electronic Data Capture module for the OATS-I study can capture and store 700+ data points over several visits for each study participant. The coordinating study team can view data from all centres worldwide in real-time to confirm data quality, use the analysis engine, and provide clinical research and technical support, where necessary.
Commenting on this innovation award, Prof. McCabe said: “One of the challenges in running large, investigator-led, multi-centre clinical research studies, such as OATS-I, is access to a reliable and affordable software platform for standardised capture, monitoring, and analysis of study data at each site. In this clinically-important multi-centre study which we are coordinating from TCD/TUH, development of a ‘bespoke’ Electronic Case Report Form (E-CRF) in close collaboration with partners at Acquis BI is facilitating achievement of these goals via centralised entry of clinical translational research data from national and international centres on the AcquisHEALTH user-friendly software platform”.
Positive Outcomes and the Future of OATS-I
The Acquis/OATS-I Clinical Research Software Platform Project was successfully launched in 2021. All OATS-I research study data are entered onto the AcquisHealth system, thus enabling the research team to focus on recruitment, clinical and laboratory assessment and follow-up of study participants, and to plan centralised data monitoring, analysis and interpretation at pre-specified timepoints. This solution will help contribute to enhancements in our knowledge base, and hopefully enable personalised care of patients with TIA and ischaemic stroke in the foreseeable future to reach our goal of improving individual patient outcomes by reducing the risk of recurrent vascular events and vascular dementia.
Stroke is a major public health issue, with over 1.1 million strokes and almost half a million stroke-related deaths every year in Europe alone. Stroke also affects people of all ages, with 26-38% of hospitalised stroke patients noted to be under the age of 65 years (Irish National Audit of Stroke National report, 2020; CDC, 2022). The direct and indirect annual costs of stroke care are enormous (€45 billion expenditure in Europe in 2015 [Stroke Alliance for Europe], and nearly $53 billion in the United States between 2017-2018 [CDC]).
“Ischaemic stroke is a leading cause of death and acquired physical disability in adults in middle-high income countries. Through our mission with TUH/TCD and the OATS-I collaborators, we strive to enable innovative research to improve our knowledge of how effective certain antiplatelet treatment regimens are following TIA and ischaemic stroke through better communication platforms, with a view to personalised antiplatelet treatment in the near future. The fact that TUH actually has an Innovation Centre clearly shows that the Hospital and TCD are committed to innovative advances in healthcare, which, in itself, is inspiring.” - Audrey McKeown, CEO Acquis BI
If our study hypotheses are proven, the OATS-I team, supported by our successful partnership with Acquis Bi, plan to use the data from this study to fine-tune the design of a definitive, multi-centre interventional treatment trial in patients with HTPR. During this process, we aspire to developing a Clinical Decision Support System (CDSS), built on top of the AcquisHEALTH Analysis Engine, to ‘auto-prompt’ clinical researchers to consider altering antiplatelet treatment in individual TIA/ischaemic stroke patients who have HTPR. This secure CDSS has the potential to be integrated into a compatible electronic health platform in future, accessible to designated health care providers and end-users.
Our long-term vision is that these secure data will enable HTPR-tailored therapy in individual patients following TIA/ischaemic stroke, thus providing a unique opportunity for pragmatic, more clinically-effective and cost-effective treatment to prevent disability or death secondary to recurrent vascular events and vascular dementia in future.
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Kathleen Merz Joanne Coffey
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