Clinical trial NCT05263804: CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke - HIBISCUS-STROKE II
Official title: CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Keywords: Ischemic stroke
Stroke
Bio-collection
Imaging markers
Biomarkers
Clinical outcomes
Myocardial damages
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
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.
timeFrame: At month 3
Secondary outcomes:
measure: Population description (Age, sex, risk factors, comorbidity, etc.)
timeFrame: At day 5 (± 2 days) after une initial hospitalization
measure: Recanalization efficacy
timeFrame: During the procedure (endovascular treatment)
measure: Long-term hemorrhagic onset
timeFrame: Day 1 after une initial hospitalization
measure: Degree of disability (mRS Score)
timeFrame: Up to 1 year
measure: Quality of life (EQ5D questionnaire)
timeFrame: At 3, 12 months
measure: Research of potential new markers
timeFrame: At month 49
measure: Myocardial damage from the ischemic stroke
timeFrame: Day 6 (±2days)
measure: Levels of NTproBNP and troponin
timeFrame: Day 6 (±2days)
measure: Research of potential new biomarkers
timeFrame: Day 6 (±2days)
measure: Evaluation of the fecal bacterial microbiological profile
timeFrame: At Day 1, at month 3
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Pierre Wertheimer, GHE
Study officials:
References: