Intra Cerebral Hemorrhage, Stroke
Conditions
Keywords
Intra Cerebral Hemorrhage, Perihaematomal oedema, MRI, outcome
Brief summary
In 2020, IntraCerebral Haemorraghe (ICH) remains the most devastating type of stroke. Besides stroke unit care, no specific treatment has been proven effective yet. Perihaematomal oedema (PHO) could be a promising therapeutic target. However, the mechanisms, the natural history as well as the clinical impact of this PHO remain unclear. The COPITCH study has been designed to answer these questions
Interventions
RADIATIONBrain MRI
Brain MRI will include differents sequences.
BIOLOGICALBiological biomarkers
Biological biomarkers will include a set of systemic inflammatory markers
Sponsors
University Hospital, Lille
Conseil Régional Hauts-de-France, France
Fondation pour la recherche sur les AVC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* With a spontaneous ICH, i.e. non traumatic * Admitted within 12 hours of stroke onset. For wake-up strokes, time of last seen well will be considered as stroke onset * Patient insured under the French social security * Consent form signed
Exclusion criteria
* Pure intraventricular haemorrhages * "secondary" ICH: ICH resulting from intracranial vascular malformation, intracranial venous thrombosis, head trauma or tumour; haemorrhagic transformation within an infarct * Pre-admission modified Rankin score of 4 or 5 * Life expectancy of less than 1 year related to comorbidities (end stage cancer, end stage organ failure) * Pregnancy or breastfeeding or Women of childbearing age without effective contraception (a pregnancy test will be done) * Adults who are deprived of their liberty by judicial or administrative decision * Referral from other hospitals * Contra-indication to MRI : claustrophobia, ocular metallic foreign bodies (accidental or other) or in a risk area (nervous or vascular system);irremovable implanted medical device (pacemaker, neurostimulator, cochlear implants and others);metallic heart valve (mainly old heart valves) or vascular clips previously implanted on cranial aneurysms; gadolinium allergy * No consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Poor functional outcome defined as a modified Rankin Scale of 4 or more | at 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall distribution of the modified Rankin scale at 3- and 12 months | at 3 months and 12 months | The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death. |
| Early neurological deterioration defined as more than 4 points on the NIHSS score | at 96 hours | The NIHSS score (NIH Stroke Scale) is used to monitor the progression of an ischemic or hemorrhagic stroke. It is rated from 0 to 42 points. Depending on the result, a distinction is made from Minor stroke to Severe stroke |
| all-cause mortality at 3 and 12 months | at 3 and 12 months | — |
| Cognitive decline | at 3 months, at 12 months | Cognitive decline defined as a score on MOCA test below 27 |
Countries
France
Contacts
CONTACTCharlotte Cordonnier, MD,PhD
PRINCIPAL_INVESTIGATORCharlotte Cordonnier, MD,PhD
University Hospital, Lille
Outcome results
None listed