Periodic Reporting for period 1 - iTrust (In-time TReatment of acUte ischaemic STroke)
Reporting period: 2019-05-01 to 2020-04-30
One great challenge in AIS contexts is the hyper-critical nature of the disease. In 2006, Jeffrey L. Saver reported that close to 2 million brain cells die each minute an artery is occluded. Hence, the most important aspect of AIS management is identification of patients eligible for timely intervention either pharmaceutically or mechanically, which defines the overarching objective of the iTrust solution.
Today the complex and time-critical therapeutic decision on AIS relies on the availability of expert stroke radiologists. However, many hospitals lack the facilities to support the standards of comprehensive stroke care, which result in only about 30% of AIS patients receiving specialized stroke unit care across Europe according to Mikulik et al (2017). Standardization of diagnosis and care across clinical levels of expertise, e.g. specialized stroke clinic to peripheral intensive care units is therefore of utmost importance. Standardization of image analysis relevant for AIS cases according to the American Heart Association (AHA) is a key element in the iTrust project, supporting AIS workflow in radiological settings from non-contrast CT scans to advanced multi-modality MRI scans.
On the product development side, quite a bit has been achieved including all necessary steps to handle data I/O, processing of data, and AI algorithms to support the disease specific region of interest finding. In addition, the AI technologies have been streamlined and expanded upon, which ensures fast and efficient development with compliance to regulatory requirements naturally fulfilled. In addition, initial updates to the end-user facing parts of the product has been received from a subcontractor based on feedback from clinicians sourced during the market research and UX activities.
Regulatory wise, the internal quality management system (QMS) was audited by a notified body and received ISO13485 certification. In addition, an initial release of Cercare Medical software was used to attain MDD (medical device directive) certification. Hence, the European part of the regulatory compliance is progressing fully according to the planned activities.