Cohort of Ischemic STROKE Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke.
Overview
Ischemic stroke is the first cause of acquired disability of the adult, the second cause of dementia and the third cause of death in the industrialized countries, what constitutes à major public health issue. Stroke is characterized by a cerebral parenchymal lesion due to an ischemic mechanism (85% of the cases) or hemorrhagic mechanism (15%). For a long time, the only approved treatment was the intravenous thrombolysis (rt-PA). Recently, thrombectomy has proven its superiority in this pathology. Cohorts of patients with stroke are rare but can be very valuable by their clinical, laboratory and imaging well documented. They are the source of new hypotheses for research or interventions as well as the quality of care assessment tool. The main objective of this project is to identify new markers: biological and imaging, treatment response and prognosis after ischemic stroke. Secondary objectives of the HIBISCUS-STROKE cohort are to establish a clinical database, completed by biological samples and by imaging data that can be used in the following areas: * Descriptive epidemiology of ischemic stroke and cerebral reperfusion, * Pharmacoepidemiology and treatments observatory: safety, efficacy, indication of treatment in real life, costs * Assessment of the long-term effect of the treatment on the occurrence of disability, stroke recurrence and death, * Quality of life and personal, familial, professional and social consequences of stroke, * Research of new diagnostic and prognostic biomarkers, * Research projects.
Primary outcome measures
- Degree of disability (mRS Score) [Time frame: 5 years]
Secondary outcome measures (4)
- infarct size [Time frame: day 6]
- Hemorrhagic transformation [Time frame: 24 hours]
- Neurological deficit [Time frame: up to 5 years]
- Quality of life [Time frame: up to 5 years]
Eligibility criteria
Inclusion criteria
- Age> 18 years
- Ischemic Stroke confirmed by MRI
- Proximal arterial occlusion (ICA or M1)
- Eligible for thrombolysis and/or thrombectomy
Exclusion criteria
- Patients residing> 50 km from the Pierre Wertheimer Hospital (Lyon, France)
- Inability to perform the first sample (H0)
- Patient with progressive or uncontrolled cancer.
- Refusal to participate in the study or to sign the consent
- Lack of medical social coverage
- Deprivation of civil rights
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital neurologique Pierre Wertheimer (Lyon) — Bron
Publications
- Bani-Sadr A, Hermier M, de Bourguignon C, Mechtouff L, Eker OF, Cappucci M, Tommasino E, Martin A, Cho TH, Derex L, Nighoghossian N, Berthezene Y. Oxygen Extraction Fraction Mapping on Admission Magnetic Resonance Imaging May Predict Recovery of Hyperacute Ischemic Brain Lesions After Successful Thrombectomy: A Retrospective Observational Study. Stroke. 2024 Nov;55(11):2685-2693. doi: 10.1161/STRO PMID 39391984
Identifiers
NCT: NCT03149705 · 69HCL17_0323