Hôpital Pierre Wertheimer, GHE
Bron, 69500, France
Location status: Recruiting
NCT Number: NCT05263804
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Bron, 69500, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Ancillary Study Inclusion Criteria:
Exclusion criteria
Ancillary Study Exclusion Criteria:
No intervention. Collection of blood samples and MRI imaging in order to create a bio- and imaging-collection
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.
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.
Time frame: At day 5 (± 2 days) after une initial hospitalization
Descriptive Epidemiology of the study population
Time frame: During the procedure (endovascular treatment)
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: Day 1 after une initial hospitalization
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: Up to 1 year
Degree of disability: modified Rankin Score
Time frame: At 3, 12 months
The quality of life of the patient will be assessed through the EQ5D questionnaire
Time frame: At month 49
Research of new markers such as inflammatory cytokines (IL-6, IL-8, IL-10).
Time frame: Day 6 (±2days)
Assessment of the irreversible lesions due to myocardial ischemia evaluated on MRI at day 6
Time frame: Day 6 (±2days)
NTproBNP and troponin level measurement
Time frame: Day 6 (±2days)
Research of potential new biomarkers such as marker of the hematoencephalic barrier damages (MMP9)
Time frame: At Day 1, at month 3
Evaluation of the fecal microbiological profile by 16S sequencing
Contact information is provided by the study sponsor or research team.
Hospices Civils de Lyon
Other
CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke
Acronym: HIBI STROKE II
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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