DIAGNOSIS study
Research type
Research Study
Full title
DIAGnosis using NOvel technology for Subtypes In Stroke (DIAGNOSIS study)
IRAS ID
351335
Contact name
Ibrahim Alghamdi
Contact email
Sponsor organisation
University of Manchester
ISRCTN Number
ISRCTN35174477
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
This study aims to improve the early diagnosis of specific stroke subtypes in suspected stroke patients. Stroke is a life-threatening condition, and different types of stroke, such as intracerebral haemorrhage (ICH) and large vessel occlusion (LVO), require different and very urgent treatments. Current stroke recognition tools used by ambulance services can predict strokes but nearly half of the patients identified using these tests have another diagnosis (sometimes called a 'stroke mimic'), which can lead to delays in appropriate care. Furthermore, current tests cannot distinguish between stroke subtypes.
Our study will investigate whether a new point-of-care blood test (LVOne test) can help differentiate stroke types quickly by measuring specific markers in the blood. These markers include glial fibrillary acidic protein (GFAP) and D-dimer which can indicate specific stroke types. In this study, we will collect blood samples from patients soon after they arrive at the hospital and compare the test results with brain imaging diagnoses.
The study will enrol 257 suspected stroke patients across three major stroke centres in the UK, including both confirmed stroke cases and stroke mimics. We aim to develop reliable diagnostic models that could be used by paramedics to guide immediate care and transport decisions, reducing delays and improving outcomes for stroke patients. If successful, this research could help shift prehospital stroke care from general screening to more targeted diagnoses, benefiting patients and ensuring the efficient use of resources for stroke patients.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
25/YH/0102
Date of REC Opinion
1 Aug 2025
REC opinion
Further Information Favourable Opinion