CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Degree of disability (mRS Score)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Degree of disability (mRS Score)
Time Frame: 5 years
Degree of disability: modified Rankin Score
Secondary Outcomes
- infarct size(day 6)
- Hemorrhagic transformation(24 hours)
- Neurological deficit(up to 5 years)
- Quality of life(up to 5 years)