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Cohort of Ischemic STROKE Patients

CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03149705
Acronym
HIBISCUSSTROKE
Enrollment
300
Registered
2017-05-11
Start date
2016-10-13
Completion date
2026-10-31
Last updated
2020-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

Ischemic stroke, stroke, bio-collection, Imaging markers, biomarkers, clinical outcomes

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.

Interventions

None listed

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Degree of disability (mRS Score)5 yearsDegree of disability: modified Rankin Score

Secondary

MeasureTime frameDescription
infarct sizeday 6cerebral infarct size on MRI
Hemorrhagic transformation24 hoursHemorrhagic transformation (ECASS scale) on imaging (CT or MRI)
Neurological deficitup to 5 yearsNeurological deficit NIH stroke Scale
Quality of lifeup to 5 yearsQOL questionnaire

Countries

France

Contacts

Primary ContactNorbert NIGHOGHOSSIAN, Prof
GHE.CICLYON@chu-lyon.fr+33 4 72 35 71 70
Backup ContactNathan MEWTON, MD, PhD
GHE.CICLYON@chu-lyon.fr+33 472 357 231

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026