Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05263804

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

Led by Hospices Civils de Lyon · Updated on 2026-02-27

500

Participants Needed

1

Research Sites

366 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Ischemic stroke confirmed by MRI
  • Proximal arterial occlusion (M1 and/or M2)
  • Eligible for thrombolysis and/or thrombectomy
  • Signed informed consent by the patient or next of kin
  • Patient has a social security number
  • For ancillary study: eligible for the main cohort and signed ancillary study consent
Not Eligible

You will not qualify if you...

  • Unable to complete 3-month follow-up at Pierre Wertheimer Hospital (Lyon, France)
  • Progressive or uncontrolled cancer
  • Deprivation of civil rights
  • Pregnant woman or woman of childbearing age without proof of no current pregnancy
  • For optional fecal library: recent antibiotic, probiotic, or rebiotic use; gastrointestinal surgeries or conditions that alter microbiota
  • Contraindication to MRI with gadolinium injection or cardiac MRI
  • Glomerular filtration rate less than 30 ml/min
  • History of coronary artery disease

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hôpital Pierre Wertheimer, GHE

Bron, France, 69500

Actively Recruiting

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Research Team

T

Tae-Hee CHO, MD, PhD

CONTACT

N

Naoual EL-JONHY

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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