Imaging cerebral neuro-inflammation in acute and chronic cerebrovascular disease: a predictor of outcome and biomarker for guiding treatment (IN-CVD)

Phase 2

Completed

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

• Registration Number: ISRCTN13797354
• Lead Sponsor: The Christie NHS Foundation Trust

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/32023020/ (added 10/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-20
• Study Completion: 2019-12-01
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Ischemic stroke in middle cerebral artery territory
2. Mild to moderate severity (Modified Rankin Scale score 2 or 3)

Exclusion Criteria

1. Neurological diagnosis of neurodegenerative disease
2. Inability to understand study information and/or express willingness to consent to the study due to communication difficulties (patients that wish to consent but are unable to sign or mark the consent form due to mobility issues may give their consent orally in the presence of at least one witness, who must sign the consent form as evidence that the information was accurately explained to and understood by the subject and that consent was freely given)
3. History of brain surgery, brain tumour, neuroinflammatory or neurodegenerative disease
4. Severe uncontrolled systemic illness
5. Patients in whom carotid endarterectomy/carotid stenting is due to be carried out within three months of recruitment to the study
6. Treatment with other drugs known to influence microglial activation, e.g. minocycline or cortical steroids (2 weeks prior to date of stroke)
7. Pregnancy
8. Contraindications to MRI scanning

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between inflammation and the clinical outcome at 3 months after having a stroke. The clinical outcome is measured using the National Institutes of Health Stroke Scale Assessment (NIHSS), and the Modified Rankin Scale Assessment (mRS). These will be able to determine the extent of injury caused by the stroke.

Secondary Outcome Measures

Name	Time	Method
Tolerability of the [18F]GE-180 scan as assessed by a patient-completed questionnaire asked at the end of the scans.