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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpital Pierre Wertheimer, GHE
RECRUITING
Bron
Contact Information
Primary
Tae-Hee CHO, MD, PhD
tae-hee.cho@chu-lyon.fr
+33 4 72 35 71 70
Backup
Naoual EL-JONHY
naoual.el-jonhy@chu-lyon.fr
+33 4 72 35 71 70
Time Frame
Start Date: 2022-05-22
Estimated Completion Date: 2029-06
Participants
Target number of participants: 500
Treatments
Other: Cohort group
Patient over 18 with an ischemic stroke
Experimental: Ancillary study group
Patient over 18 with an ischemic stroke
Sponsors
Leads: Hospices Civils de Lyon

This content was sourced from clinicaltrials.gov