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NCT Number: NCT03149705

Cohort of Ischemic STROKE Patients

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital neurologique Pierre Wertheimer (Lyon)

Bron, 69500, France

Location status: Recruiting

Location contact

Nathan Mewton, MD, PhD

CONTACT

[email protected]

+33 472 357 231

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Degree of disability (mRS Score)

    Time frame: 5 years

    Degree of disability: modified Rankin Score

Secondary outcomes

  1. infarct size

    Time frame: day 6

    cerebral infarct size on MRI

  2. Hemorrhagic transformation

    Time frame: 24 hours

    Hemorrhagic transformation (ECASS scale) on imaging (CT or MRI)

  3. Neurological deficit

    Time frame: up to 5 years

    Neurological deficit NIH stroke Scale

  4. Quality of life

    Time frame: up to 5 years

    QOL questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Nathan MEWTON, MD, PhD

CONTACT

[email protected]

+33 472 357 231

Norbert NIGHOGHOSSIAN, Prof

CONTACT

[email protected]

+33 4 72 35 71 70

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: HIBISCUSSTROKE

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
May 11, 2017
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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