Topic: Stroke
Conditions
Interventions
This is an observational study, thus no intervention is being tested. Baseline assessment will include demographics, premorbid health and medications, details of presenting signs and symptoms, clinica
Sponsors
University of Manchester (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 or over 2. Acute, spontaneous, supratentorial ICH within 24 h of symptom onset 3. Glasgow coma scale (GCS) score = 9 4. Research MR scan can be performed within 3 days of symptom onset Additional inclusion criteria for PET imaging (d 27): 5. GCS = 14 6. Able to transfer from chair to bed with assistance of two people 7. Deemed medically stable by medically qualified researcher for transfer to Wolfson Molecular Imaging Centre (WMIC) on day of PET scan
Exclusion criteria
Exclusion criteria: 1. Contraindication to magnetic resonance (MR) scanning 2. Pre-existing brain lesion (e.g. tumour, previous stroke) that is likely to interfere with the planned analysis 3. ICH known or strongly suspected of being secondary to a structural vascular malformation (e.g. cerebral aneurysm, arteriovenous malformation, cavernoma, dural arteriovenous fistula), tumour, haemorrhagic transformation of an ischaemic stroke, or venous sinus thrombosis 4. Clear history of recent (<7 days prior to onset) head trauma, thought to be the cause of intracerebral haemorrhage 5. Any known inflammatory disease which in the opinion of the PI may interfere with interpretation of the study results 6. Known, uncorrected bleeding disorder 7. Female patient who may be pregnant or who is breastfeeding 8. Significant renal impairment (estimated glomerular filtration rate < 30) 9. Any other significant disease or disorder which, in the opinion of the PI or his delegatee, may put the participant at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study 10. Neurosurgical procedure performed since admission or booked for surgery 11. Treatment with drugs known to or likely to interfere with PK11195 binding (including benzodiazepines, steroids, minocycline) that cannot be stopped in sufficient time to prevent interference with PET scanning
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the extent to which blood-brain barrier breakdown during acute ICH co-localises with activated microglia | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine whether the magnitude and extent of blood-brain barrier breakdown is associated with haematoma size and location after ICH 2. Perform exploratory analyses testing for associations between blood-brain barrier permeability and brain inflammation with peripheral inflammatory markers and clinical outcomes | — |
Countries
United Kingdom
Outcome results
None listed