The MIRACLES Study

Imaging of the brain is central to the management of acute stroke and transient ischaemic attack, as it is used to confirm diagnosis, determine treatment eligibility, indicate probable mechanism, inform prognosis, and identify complications of stroke or its treatment. 

Magnetic Resonance Imaging (MRI), especially the Diffusion Weighted Imaging (DWI) sequence, is particularly effective in this context as it can detect early changes in brain water distribution during the initial hours following the onset of ischaemia. There are however several factors limiting MRI access, including the need for patient checks for metal implants, challenges in monitoring unwell patients, and issues with claustrophobia due to the confined space and lengthy imaging times (15-30 minutes). 

To address these issues, Hyperfine have designed the Swoop system. This is a small, portable MRI scanner which produces a low magnetic field (0.064 Tesla) to enable scanning at the bedside, with technology that can cancel out background electromagnetic interference in clinical settings. 

About the Study 

The MIRACLES study is investigating the potential value of the Hyperfine Swoop MRI scanner in patients with suspected or proven acute stroke and transient ischaemic attack (TIA). 

Using the Swoop system, the study will perform additional imaging on eligible patients—those presenting within 7 days of symptom onset of either suspected or confirmed stroke or transient ischaemic attack (mini-stroke) at the emergency department of the Queen Elizabeth University Hospital. 

This imaging will be compared to routine imaging obtained as part of the usual standard of care to assess diagnostic accuracy and DWI lesion volume. The study will also evaluate ease of use, tolerability and image quality of the Swoop system. 

How DHVL Supported this Study

The Digital Health Validation Lab has provided a Clinical Innovation Fellow to organise the MIRACLES study, recruit and follow up with patients, operate the scanner, and maintain and report on all study activities. 

Additionally, DHVL has facilitated connections with NHS Safe Haven and effectively bridged communication between NHS physicians, Research & Innovation, the emergency department (ED), stroke team, and research nurses. 

The team also led on the collaboration with three American sites for a combined study utilising data from MIRACLES.