Идёт набор NCT05263804

CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke - HIBISCUS-STROKE II

Без фазы С лечением Ischemic Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Collection of blood samples and MRI imaging in order to create a bio- and imaging-collection, Cardiac MRI with gadolinium injection - Ancillary Study.
Кому может быть актуально: Состояния в реестре: Ischemic Stroke. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

CoHort of Patients to Identify Biological and Imaging markerS of CardiovascUlar Outcomes in Stroke

Обзор

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.

Вмешательства

Другое Collection of blood samples and MRI imaging in order to create a bio- and imaging-collection
No intervention. Collection of blood samples and MRI imaging in order to create a bio- and imaging-collection
Другое Cardiac MRI with gadolinium injection - Ancillary Study
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.

Первичные конечные точки

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. [Срок оценки: At month 3]

Вторичные конечные точки (10)

Population description (Age, sex, risk factors, comorbidity, etc.) [Срок оценки: At day 5 (± 2 days) after une initial hospitalization]
Recanalization efficacy [Срок оценки: During the procedure (endovascular treatment)]
Long-term hemorrhagic onset [Срок оценки: Day 1 after une initial hospitalization]
Degree of disability (mRS Score) [Срок оценки: Up to 1 year]
Quality of life (EQ5D questionnaire) [Срок оценки: At 3, 12 months]
Research of potential new markers [Срок оценки: At month 49]
Myocardial damage from the ischemic stroke [Срок оценки: Day 6 (±2days)]
Levels of NTproBNP and troponin [Срок оценки: Day 6 (±2days)]
Research of potential new biomarkers [Срок оценки: Day 6 (±2days)]
Evaluation of the fecal bacterial microbiological profile [Срок оценки: At Day 1, at month 3]

Критерии участия

Критерии включения

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

Критерии исключения

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: