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Clinical Trials/NCT03149705
NCT03149705
Recruiting
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country300 target enrollmentOctober 13, 2016
ConditionsIschemic Stroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Stroke
Sponsor
Hospices Civils de Lyon
Enrollment
300
Locations
1
Primary Endpoint
Degree of disability (mRS Score)
Status
Recruiting
Last Updated
5 years ago

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.
Registry
clinicaltrials.gov
Start Date
October 13, 2016
End Date
October 2026
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

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)

Study Sites (1)

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