NCT05263804: HIBI STROKE II

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

Recruiting now NA Last updated 26 February 2026

What this trial tests

NA trial testing Collection of blood samples and MRI imaging in order to create a bio- and imaging-collection in Ischemic Stroke in 500 participants. Currently enrolling.

Timeline

22 May 2022

Primary endpoint
1 June 2029

1 June 2029

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	500
Start date	22 May 2022
Primary completion	1 June 2029
Estimated completion	1 June 2029
Sites	1 location across France

Drugs / interventions tested

• Collection of blood samples and MRI imaging in order to create a bio- and imaging-collection
• Cardiac MRI with gadolinium injection - Ancillary Study

Conditions studied

• Ischemic Stroke — all drugs for Ischemic Stroke →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.
  Time frame: At month 3
  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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.