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

Ischemic Stroke Clinical Trial

— HIBI STROKE II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05263804
• Other study ID #: 69HCL20_1003
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2022
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: Hospices Civils de Lyon
• Contact: Tae-Hee CHO, MD, PhD
• Phone: +33 4 72 35 71 70
• Email: tae-hee.cho[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Other:
• 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
• 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.

Locations

Country	Name	City	State
France	Hôpital Pierre Wertheimer, GHE	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At month 3
Secondary	Population description (Age, sex, risk factors, comorbidity, etc.)	Descriptive Epidemiology of the study population	At day 5 (± 2 days) after une initial hospitalization
Secondary	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.	During the procedure (endovascular treatment)
Secondary	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)	Day 1 after une initial hospitalization
Secondary	Degree of disability (mRS Score)	Degree of disability: modified Rankin Score	Up to 1 year
Secondary	Quality of life (EQ5D questionnaire)	The quality of life of the patient will be assessed through the EQ5D questionnaire	At 3, 12 months
Secondary	Research of potential new markers	Research of new markers such as inflammatory cytokines (IL-6, IL-8, IL-10).	At month 49
Secondary	Myocardial damage from the ischemic stroke	Assessment of the irreversible lesions due to myocardial ischemia evaluated on MRI at day 6	Day 6 (±2days)
Secondary	Levels of NTproBNP and troponin	NTproBNP and troponin level measurement	Day 6 (±2days)
Secondary	Research of potential new biomarkers	Research of potential new biomarkers such as marker of the hematoencephalic barrier damages (MMP9)	Day 6 (±2days)
Secondary	Evaluation of the fecal bacterial microbiological profile	Evaluation of the fecal microbiological profile by 16S sequencing	At Day 1, at month 3