CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke - HIBISCUS-STROKE II (HIBI STROKE II)
Primary Purpose
Ischemic Stroke
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of blood samples and MRI imaging in order to create a bio- and imaging-collection
Cardiac MRI with gadolinium injection - Ancillary Study
Sponsored by
About this trial
This is an interventional other trial for Ischemic Stroke focused on measuring Ischemic stroke, Stroke, Bio-collection, Imaging markers, Biomarkers, Clinical outcomes, Myocardial damages
Eligibility Criteria
Inclusion Criteria:
- 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
Ancillary Study Inclusion Criteria:
- Eligible for the Hibiscus stroke II cohort
- Ancillary study informed consent signed by the patient or the next of kin
Exclusion Criteria:
- 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
Ancillary Study Exclusion Criteria:
- 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
Sites / Locations
- Hôpital Pierre Wertheimer, GHERecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Cohort group
Ancillary study group
Arm Description
Patient over 18 with an ischemic stroke
Patient over 18 with an ischemic stroke
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Population description (Age, sex, risk factors, comorbidity, etc.)
Descriptive Epidemiology of the study population
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.
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)
Degree of disability (mRS Score)
Degree of disability: modified Rankin Score
Quality of life (EQ5D questionnaire)
The quality of life of the patient will be assessed through the EQ5D questionnaire
Research of potential new markers
Research of new markers such as inflammatory cytokines (IL-6, IL-8, IL-10).
Myocardial damage from the ischemic stroke
Assessment of the irreversible lesions due to myocardial ischemia evaluated on MRI at day 6
Levels of NTproBNP and troponin
NTproBNP and troponin level measurement
Research of potential new biomarkers
Research of potential new biomarkers such as marker of the hematoencephalic barrier damages (MMP9)
Evaluation of the fecal bacterial microbiological profile
Evaluation of the fecal microbiological profile by 16S sequencing
Full Information
NCT ID
NCT05263804
First Posted
January 18, 2021
Last Updated
January 24, 2023
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT05263804
Brief Title
CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke - HIBISCUS-STROKE II
Acronym
HIBI STROKE II
Official Title
CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2022 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Ischemic stroke, Stroke, Bio-collection, Imaging markers, Biomarkers, Clinical outcomes, Myocardial damages
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort group
Arm Type
Other
Arm Description
Patient over 18 with an ischemic stroke
Arm Title
Ancillary study group
Arm Type
Experimental
Arm Description
Patient over 18 with an ischemic stroke
Intervention Type
Other
Intervention Name(s)
Collection of blood samples and MRI imaging in order to create a bio- and imaging-collection
Intervention Description
No intervention. Collection of blood samples and MRI imaging in order to create a bio- and imaging-collection
Intervention Type
Other
Intervention Name(s)
Cardiac MRI with gadolinium injection - Ancillary Study
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
At month 3
Secondary Outcome Measure Information:
Title
Population description (Age, sex, risk factors, comorbidity, etc.)
Description
Descriptive Epidemiology of the study population
Time Frame
At day 5 (± 2 days) after une initial hospitalization
Title
Recanalization efficacy
Description
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.
Time Frame
During the procedure (endovascular treatment)
Title
Long-term hemorrhagic onset
Description
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)
Time Frame
Day 1 after une initial hospitalization
Title
Degree of disability (mRS Score)
Description
Degree of disability: modified Rankin Score
Time Frame
Up to 1 year
Title
Quality of life (EQ5D questionnaire)
Description
The quality of life of the patient will be assessed through the EQ5D questionnaire
Time Frame
At 3, 12 months
Title
Research of potential new markers
Description
Research of new markers such as inflammatory cytokines (IL-6, IL-8, IL-10).
Time Frame
At month 49
Title
Myocardial damage from the ischemic stroke
Description
Assessment of the irreversible lesions due to myocardial ischemia evaluated on MRI at day 6
Time Frame
Day 6 (±2days)
Title
Levels of NTproBNP and troponin
Description
NTproBNP and troponin level measurement
Time Frame
Day 6 (±2days)
Title
Research of potential new biomarkers
Description
Research of potential new biomarkers such as marker of the hematoencephalic barrier damages (MMP9)
Time Frame
Day 6 (±2days)
Title
Evaluation of the fecal bacterial microbiological profile
Description
Evaluation of the fecal microbiological profile by 16S sequencing
Time Frame
At Day 1, at month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Ancillary Study Inclusion Criteria:
Eligible for the Hibiscus stroke II cohort
Ancillary study informed consent signed by the patient or the next of kin
Exclusion Criteria:
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae-Hee CHO, MD, PhD
Phone
+33 4 72 35 71 70
Email
tae-hee.cho@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marielle BUISSON
Phone
+33 4 72 35 71 70
Email
marielle.buisson01@chu-lyon.fr
Facility Information:
Facility Name
Hôpital Pierre Wertheimer, GHE
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae-Hee CHO, MD, PhD
Phone
+33 4 72 35 71 70
Email
tae-hee.cho@chu-lyon.fr
12. IPD Sharing Statement
Learn more about this trial
CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke - HIBISCUS-STROKE II
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