NCT04971564 Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia
| NCT ID | NCT04971564 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
| Condition | Cerebral Hypoxia |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-03-19 |
| Primary Completion | 2026-06-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-03-19 with a primary completion date of 2026-06-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this trial is to study, in three well-defined clinical situations responsible for cerebral hypoxia, the concentrations of biomarkers of thrombo-inflammation compared to a population of patients without cerebral hypoxia, and to study in patients with cerebral hypoxia the association between these concentrations and the clinical evolution.
Eligibility Criteria
Inclusion Criteria: \- For cases, admitted within the first 36 hours of an acute neurological symptom related to : * An ischaemic cerebrovascular accident (iCVA) eligible for a mechanical thrombectomy procedure, * A subarachnoid haemorrhage (SAH, all aetiologies) : patient presenting with at least a modified Fisher scale 3 or 4, * An intra-parenchymal haematoma (IPH) with greatest axis ≥ 20mm or with NIHSS on admission \>4. OR * For control patients, admitted within 7 days of the onset of acute neurological symptomatology related to a clinical diagnosis of transient ischaemic attack (TIA) - based on thorough questioning of the patient on admission - and prior to imaging, with an ABCD2≥ 2 score. * Express consent to participate in the study. * Member or beneficiary of a social security. Exclusion Criteria: * Pre-existing functional and/or cognitive disability * Patient under legal protection. * Pregnant or breastfeeding woman. * Patient with secondary haemorrhagic transformation. Secondary exclusion criteria : * Patients with an ischaemic lesion visible on imaging, unrelated to large vessel occlusion and therefore ineligible for mechanical thrombectomy. * Patients diagnosed with an acute non-vascular neurological pathology (migraine, epilepsy, etc.). * TIA patients presenting an abnormality on follow-up imaging 24-48 hours after the initial imaging. Excluded patients will be replaced.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04971564 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cerebral Hypoxia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04971564 currently recruiting?
Yes, NCT04971564 is actively recruiting participants. Contact the research team at fdelvoye@for.paris for enrollment information.
Where is the NCT04971564 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04971564 clinical trial?
NCT04971564 is sponsored by Fondation Ophtalmologique Adolphe de Rothschild. The trial plans to enroll 200 participants.