Cohort of Ischemic STROKE Patients

Recruiting

• Conditions: Ischemic Stroke

• Registration Number: NCT03149705
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-13
• Study First Submitted: 2017-05-09
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-12
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age> 18 years
• Ischemic Stroke confirmed by MRI
• Proximal arterial occlusion (ICA or M1)
• Eligible for thrombolysis and/or thrombectomy

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Degree of disability (mRS Score)	5 years	Degree of disability: modified Rankin Score

Secondary Outcome Measures

Name	Time	Method
infarct size	day 6	cerebral infarct size on MRI
Hemorrhagic transformation	24 hours	Hemorrhagic transformation (ECASS scale) on imaging (CT or MRI)
Neurological deficit	up to 5 years	Neurological deficit NIH stroke Scale
Quality of life	up to 5 years	QOL questionnaire

Trial Locations

Locations (1)

Hôpital neurologique Pierre Wertheimer (Lyon); 🇫🇷 Bron, France