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NCT05263804Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 27 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
500 (estimated)
First submitted
18 Jan 2021
Start date
22 May 2022
Primary completion date
Jun 2029
Lead sponsor
Hospices Civils de Lyon
Diseases
Stroke
NCT number
NCT05263804

What you commit to

  • Study type: Interventional
  • Planned participants: 500
  • From 22 May 2022 to the primary completion date, Jun 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patient with progressive or uncontrolled cancer.
  • 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 cardiac MRI (including inability to perform cardiac MRI)
  • History of coronary artery disease

Age

  • Pregnant woman or woman of childbearing age without proof of the absence of a current pregnancy

Other

  • 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)
  • Deprivation of civil rights
  • Contraindication to MRI with gadolinium injection
  • Patients with a glomerular filtration rate \<30ml/min

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hôpital Pierre Wertheimer, GHE
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BronFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.