Intracerebral haemorrhage: Imaging microglial activation and blood­brain barrier leakage (IMAGE-ICH)

Not Applicable

• Conditions: Topic: Stroke; Subtopic: Acute Care; Disease: In hospital study, Community study; Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN52682983
• Lead Sponsor: niversity of Manchester (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-22
• Last Update Posted: 3 August 2020
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 55

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the extent to which blood-brain barrier breakdown during acute ICH co-localises with activated microglia

Secondary Outcome Measures

Name	Time	Method
<br> 1. To determine whether the magnitude and extent of blood-brain barrier breakdown is associated with haematoma size and location after ICH<br> 2. Perform exploratory analyses testing for associations between blood-brain barrier permeability and brain inflammation with peripheral inflammatory markers and clinical outcomes<br>