Ischemic StrokeHIBI STROKE IINCT05263804
CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke - HIBISCUS-STROKE II
A study testing Collection of blood samples and MRI imaging in order to create a bio- and imaging-collection and Cardiac MRI with gadolinium injection - Ancillary Study in people with 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
- What is being tested?
- Collection of blood samples and MRI imaging in order to create a bio- and imaging-collection and Cardiac MRI with gadolinium injection - Ancillary Study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 22 May 2022to Jun 2029
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years
- Ischemic Stroke confirmed by MRI
- Proximal arterial occlusion (M1 and/or M2)
- Eligible for thrombolysis and/or thrombectomy
- Informed consent signed by the patient or the next of kin
- Patient with a social security number
Show all 9Show fewer
- Ancillary Study Inclusion Criteria:
- Eligible for the Hibiscus stroke II cohort
- Ancillary study informed consent signed by the patient or the next of kin
Who cannot join
- Patients for whom it is known at the inclusion that follow-up at 3 months will not be possible at Pierre Wertheimer Hospital (Lyon, France)
- Patient with progressive or uncontrolled cancer.
- Deprivation of civil rights
- Pregnant woman or woman of childbearing age without proof of the absence of a current pregnancy
- For patients participating in the optional fecal library: factors leading to a potential change in microbiota (antibiotic therapy within 3 months, probiotic or rebiotic use within 3 months, ileo or gastrostomy, gastrointestinal resection surgery, bariatric or peptic ulcer surgery, Crohn's disease or chronic inflammatory bowel disease, helicobacter pylori gastric ulcer less than 1 year old, participation in a study that aims to modify the microbiota)
- Ancillary Study Exclusion Criteria:
Show all 10Show fewer
- Contraindication to MRI with gadolinium injection
- Contraindication to cardiac MRI (including inability to perform cardiac MRI)
- Patients with a glomerular filtration rate <30ml/min
- History of coronary artery disease
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 Pierre Wertheimer, GHE
Bron, 69500
Tae-Hee CHO, MD, PhD, +33 4 72 35 71 70, tae-hee.cho@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 II 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.
Ancillary study :
Cardiac complications are the second leading cause of death after stroke. A close relationship between brain damage and heart complications, referred to as "neuro-cardiac syndrome" has been established. 20% of patients admitted for ischemic stroke present at least one major cardiac event, including acute coronary syndrome, heart failure and / or cardiac arrhythmia, within three months of the event, while 28% have a left ventricular ejection fraction less than 50%. However, the underlying pathological mechanisms remain unclear and the therapeutic targets unknown. To study these mechanisms, an ancillary study will be proposed to patient whom accepted to participate in the main project research.
The general objective of the ancillary study is to identify early markers of cardiac damage during ischemic stroke having benefited from mechanical recanalization by thrombectomy, and to improve the understanding of the pathophysiology at the origin of cardiac complications in the course of an ischemic stroke with the final objective of identifying new therapeutic targets.
- Conditions
- Ischemic Stroke
- Being tested
- Collection of blood samples and MRI imaging in order to create a bio- and imaging-collection, Cardiac MRI with gadolinium injection - Ancillary Study
- Keywords
- Ischemic stroke, Stroke, Bio-collection, Imaging markers, Biomarkers, Clinical outcomes, Myocardial damages
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of blood samples and MRI imaging in order to create a bio- and imaging-collectionOther
No intervention. Collection of blood samples and MRI imaging in order to create a bio- and imaging-collection
Cardiac MRI with gadolinium injection - Ancillary StudyOther
Collection of blood samples and MRI imaging in order to create a bio- and imaging-collection. 100 patients are expected in this group, for each of them, specific cardiac MRI with gadolinium injection will be done at day 6. Moreover, those 100 patients will follow the same visit schedule as the patients in the cohort group.
| Study group | Role | What they receive |
|---|---|---|
| Cohort group | Other | Patient over 18 with an ischemic stroke Receives: Other: Collection of blood samples and MRI imaging in order to create a bio- and imaging-collection |
| Ancillary study group | Experimental | Patient over 18 with an ischemic stroke Receives: Other: Cardiac MRI with gadolinium injection - Ancillary Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific primary endpoint will be established for each sub-study based on data from the HIBISCUS-Stroke II cohort such as the Rankin score at 3 months.
This study will allow the realization of various research exploiting the data collected. Each study will defined its relevant primary endpoint. The primary endpoint will most often be the Modified Rankin Scale (mRS from 0 to 6 where 6 is the worst outcome) at 3 months or the vital status at 3 months.
Measured: At month 3
Secondary outcomes (10)
Population description (Age, sex, risk factors, comorbidity, etc.)
Descriptive Epidemiology of the study population
Measured: At day 5 (± 2 days) after une initial hospitalization
Recanalization efficacy
The efficacy of revascularization will be evaluated by TICI Score (Thrombolysis In Cerebral Infarction). A grade of zero indicated a recanalization failure and a grade of 3 a complete recanalization.
Measured: During the procedure (endovascular treatment)
Long-term hemorrhagic onset
ECASS (European Cooperative Acute Stroke Study) Scale evaluation which divides hemorrhagic transformation into four subtypes from hemorrhagic infarction type 1 (HI1) to parenchymal hematoma type 2 (PH2)
Measured: Day 1 after une initial hospitalization
Degree of disability (mRS Score)
Degree of disability: modified Rankin Score
Measured: Up to 1 year
Quality of life (EQ5D questionnaire)
The quality of life of the patient will be assessed through the EQ5D questionnaire
Measured: At 3, 12 months
Research of potential new markers
Research of new markers such as inflammatory cytokines (IL-6, IL-8, IL-10).
Measured: At month 49
Myocardial damage from the ischemic stroke
Assessment of the irreversible lesions due to myocardial ischemia evaluated on MRI at day 6
Measured: Day 6 (±2days)
Levels of NTproBNP and troponin
NTproBNP and troponin level measurement
Measured: Day 6 (±2days)
Research of potential new biomarkers
Research of potential new biomarkers such as marker of the hematoencephalic barrier damages (MMP9)
Measured: Day 6 (±2days)
Evaluation of the fecal bacterial microbiological profile
Evaluation of the fecal microbiological profile by 16S sequencing
Measured: At Day 1, at month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start22 May 2022
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 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
- NCT05263804
- Sponsor's protocol ID
- 69HCL20_1003
- Acronym
- HIBI STROKE II
- Status last verified
- Feb 2026
- First submitted
- 18 Jan 2021
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. 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
- NCT05263804
- Acronym / sponsor ID
- HIBI STROKE II / 69HCL20_1003
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic stroke, Stroke, Bio-collection, Imaging markers, Biomarkers, Clinical outcomes, Myocardial damages
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 May 2022 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 3 Mar 2022 (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 II 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.
Ancillary study :
Cardiac complications are the second leading cause of death after stroke. A close relationship between brain damage and heart complications, referred to as "neuro-cardiac syndrome" has been established. 20% of patients admitted for ischemic stroke present at least one major cardiac event, including acute coronary syndrome, heart failure and / or cardiac arrhythmia, within three months of the event, while 28% have a left ventricular ejection fraction less than 50%. However, the underlying pathological mechanisms remain unclear and the therapeutic targets unknown. To study these mechanisms, an ancillary study will be proposed to patient whom accepted to participate in the main project research.
The general objective of the ancillary study is to identify early markers of cardiac damage during ischemic stroke having benefited from mechanical recanalization by thrombectomy, and to improve the understanding of the pathophysiology at the origin of cardiac complications in the course of an ischemic stroke with the final objective of identifying new therapeutic targets.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort group | Other | Other: Collection of blood samples and MRI imaging in order to create a bio- and imaging-collectionPatient over 18 with an ischemic stroke |
| Ancillary study group | Experimental | Other: Cardiac MRI with gadolinium injection - Ancillary StudyPatient over 18 with an ischemic stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Ischemic Stroke confirmed by MRI
- Proximal arterial occlusion (M1 and/or M2)
- Eligible for thrombolysis and/or thrombectomy
- Informed consent signed by the patient or the next of kin
Key exclusion criteria (10 listed)
- Patients for whom it is known at the inclusion that follow-up at 3 months will not be possible at Pierre Wertheimer Hospital (Lyon, France)
- Patient with progressive or uncontrolled cancer.
- Deprivation of civil rights
- Pregnant woman or woman of childbearing age without proof of the absence of a current pregnancy
- For patients participating in the optional fecal library: factors leading to a potential change in microbiota (antibiotic therapy within 3 months, probiotic or rebiotic use within 3 months, ileo or gastrostomy, gastrointestinal resection surgery, bariatric or peptic ulcer surgery, Crohn's disease or chronic inflammatory bowel disease, helicobacter pylori gastric ulcer less than 1 year old, participation in a study that aims to modify the microbiota)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of blood samples and MRI imaging in order to create a bio- and imaging-collectionNo intervention. Collection of blood samples and MRI imaging in order to create a bio- and imaging-collection | Other | Cohort group |
| Cardiac MRI with gadolinium injection - Ancillary StudyCollection of blood samples and MRI imaging in order to create a bio- and imaging-collection. 100 patients are expected in this group, for each of them, specific cardiac MRI with gadolinium injection will be done at day 6. Moreover, those 100 patients will follow the same visit schedule as the patients in the cohort group. | Other | Ancillary study group |
Primary outcome
Specific primary endpoint will be established for each sub-study based on data from the HIBISCUS-Stroke II cohort such as the Rankin score at 3 months.
Time frame: At month 3
This study will allow the realization of various research exploiting the data collected. Each study will defined its relevant primary endpoint. The primary endpoint will most often be the Modified Rankin Scale (mRS from 0 to 6 where 6 is the worst outcome) at 3 months or the vital status at 3 months.
10 secondary outcomes
Population description (Age, sex, risk factors, comorbidity, etc.)
Time frame: At day 5 (± 2 days) after une initial hospitalization
Recanalization efficacy
Time frame: During the procedure (endovascular treatment)
Long-term hemorrhagic onset
Time frame: Day 1 after une initial hospitalization
Degree of disability (mRS Score)
Time frame: Up to 1 year
Quality of life (EQ5D questionnaire)
Time frame: At 3, 12 months
Research of potential new markers
Time frame: At month 49
Myocardial damage from the ischemic stroke
Time frame: Day 6 (±2days)
Levels of NTproBNP and troponin
Time frame: Day 6 (±2days)
Research of potential new biomarkers
Time frame: Day 6 (±2days)
Evaluation of the fecal bacterial microbiological profile
Time frame: At Day 1, at month 3
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 27 Feb 2026.
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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?
A study testing Collection of blood samples and MRI imaging in order to create a bio- and imaging-collection and Cardiac MRI with gadolinium injection - Ancillary Study in people with 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 9 inclusion and 10 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 27 Feb 2026. 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 Tae-Hee CHO, MD, PhD (+33 4 72 35 71 70, tae-hee.cho@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific primary endpoint will be established for each sub-study based on data from the HIBISCUS-Stroke II cohort such as the Rankin score at 3 months. (time frame: At month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.