Cohort of Ischemic STROKE Patients
HIBISCUSSTROKE
CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke.
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 13, 2016
CompletedFirst Submitted
Initial submission to the registry
May 9, 2017
CompletedFirst Posted
Study publicly available on registry
May 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
August 12, 2020
August 1, 2020
10 years
May 9, 2017
August 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Degree of disability (mRS Score)
Degree of disability: modified Rankin Score
5 years
Secondary Outcomes (4)
infarct size
day 6
Hemorrhagic transformation
24 hours
Neurological deficit
up to 5 years
Quality of life
up to 5 years
Eligibility Criteria
Stroke patients
You may qualify if:
- Age\> 18 years
- Ischemic Stroke confirmed by MRI
- Proximal arterial occlusion (ICA or M1)
- Eligible for thrombolysis and/or thrombectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital neurologique Pierre Wertheimer (Lyon)
Bron, 69500, France
Related Publications (1)
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/STROKEAHA.124.047311. Epub 2024 Oct 11.
PMID: 39391984DERIVED
Biospecimen
In usual care of patients admitted for ischemic STROKE at Pierre Wertheimer Hospital, blood samples were taken on admission in the neurovascular unit (H0), 6h, 24h and 48h after reperfusion , and during the 3 month clinical visit. For the constitution of the serum bank of Hibiscus-STROKE cohort, extra tubes are collected at the same time as the blood tests done routinely. These additional samples will be centrifuged and treated to form a collection of biological samples of total serum and plasma and blood stored at the Biological Resource Center of HCL Neurobiotec at -80 ° C (DC- 2008-72, AC-2013-1867 certified NFS96900 FR13-018140).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2017
First Posted
May 11, 2017
Study Start
October 13, 2016
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
August 12, 2020
Record last verified: 2020-08