Ischemic StrokeHIBISCUSSTROKENCT03149705
Cohort of Ischemic STROKE Patients
An observational study of Ischemic Stroke, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2016to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients
Who may be able to join
- Age> 18 years
- Ischemic Stroke confirmed by MRI
- Proximal arterial occlusion (ICA or M1)
- Eligible for thrombolysis and/or thrombectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital neurologique Pierre Wertheimer (Lyon)
Bron, 69500
Nathan Mewton, MD, PhD, +33 472 357 231, GHE.CICLYON@chu-lyon.fr
About this study
Official title: CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke.
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.
Read more
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.
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic stroke, stroke, bio-collection, Imaging markers, biomarkers, clinical outcomes
- Medical subject headings
- Ischemic Stroke, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of disability (mRS Score)
Degree of disability: modified Rankin Score
Measured: 5 years
Secondary outcomes (4)
infarct size
cerebral infarct size on MRI
Measured: day 6
Hemorrhagic transformation
Hemorrhagic transformation (ECASS scale) on imaging (CT or MRI)
Measured: 24 hours
Neurological deficit
Neurological deficit NIH stroke Scale
Measured: up to 5 years
Quality of life
QOL questionnaire
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start13 Oct 2016
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149705
- Sponsor's protocol ID
- 69HCL17_0323
- Acronym
- HIBISCUSSTROKE
- Status last verified
- Aug 2020
- First submitted
- 9 May 2017
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39391984
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke.
- ClinicalTrials.gov ID
- NCT03149705
- Acronym / sponsor ID
- HIBISCUSSTROKE / 69HCL17_0323
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic stroke, stroke, bio-collection, Imaging markers, biomarkers, clinical outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 Oct 2016 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 11 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients
Key inclusion criteria (4 listed)
- Age> 18 years
- Ischemic Stroke confirmed by MRI
- Proximal arterial occlusion (ICA or M1)
- Eligible for thrombolysis and/or thrombectomy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Degree of disability (mRS Score)
Time frame: 5 years
Degree of disability: modified Rankin Score
4 secondary outcomes
infarct size
Time frame: day 6
Hemorrhagic transformation
Time frame: 24 hours
Neurological deficit
Time frame: up to 5 years
Quality of life
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Derived from this study: PubMed 39391984Bani-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norbert NIGHOGHOSSIAN, Prof (+33 4 72 35 71 70, GHE.CICLYON@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of disability (mRS Score) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03149705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.