MRI plus tissue analysis to understand clot-related bleeding and microvascular blockage after large sylvian ischemic stroke treated with hemicraniectomy
Official title: Radiohistological Correlation of Thrombohemorrhagic Remodeling in the Acute Phase of Ischemic Stroke Managed by Decompressive Hemicraniectomy
Run by Fondation Ophtalmologique Adolphe de Rothschild · NCT05847699 · Data updated 2026-11-12
This project will test whether special MRI scans combined with small brain tissue samples can better identify clot-related microvessel blockages and bleeding in adults with large sylvian ischemic strokes who need or may need decompressive hemicraniectomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild Research network |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | October 2, 2024 |
| Main results expected | October 2, 2028 |
| Study ends | January 1, 2029 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT05847699 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with sylvian ischemic stroke who require or are being evaluated for decompressive hemicraniectomy, or post-thrombectomy patients with cortical hyperdensities and the ability to consent and receive gadobutrol-enhanced MRI, are ideal candidates.
✕Probably not a fit
Patients who are pregnant or breastfeeding, legally protected, allergic to gadobutrol, have severe renal failure (creatinine clearance <15 ml/min), or who do not undergo hemicraniectomy or have minor strokes are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study pairs advanced MRI sequences with histological examination of tissue obtained during decompressive hemicraniectomy to correlate imaging findings with cellular and thrombotic remodeling in the acute phase of ischemic stroke. It focuses on patients with sylvian territory infarcts who either require or are being considered for hemicraniectomy, including some post-thrombectomy cases with cortical hyperdensities on CT. Investigators will compare radiologic signs of reperfusion and cortical hyperdensity with direct biopsy findings to distinguish recanalization from effective reperfusion and to document microvascular thrombosis and hemorrhagic remodeling. The goal is to improve understanding of why many patients have poor functional outcomes despite proximal vessel recanalization.
Why it matters
Potential benefit: If successful, the work could help clinicians identify which patients have microvascular thrombosis or thrombohemorrhagic remodeling and guide targeted therapies to improve outcomes after large ischemic strokes.
How similar studies have gone: Previous work has described post-reperfusion microvascular thrombosis and used advanced MRI markers, but direct radiohistological correlation using biopsies in the acute hemicraniectomy setting is relatively novel and limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * Managed for sylvian ischemic stroke * Requiring brain MRI as part of the evaluation for possible decompressive hemicraniectomy (DH). Or * Having undergone a post-thrombectomy brain scan showing cortical hyperdensities and indication for a possible decompressive hemicraniectomy * Consent to participate in the study * Affiliated or beneficiary of a health insurance plan Exclusion Criteria: * Absolute or relative contraindication to gadobutrol injection (history of true allergic reaction or intolerance to gadobutrol, renal insufficiency with creatinine clearance \<15ml/min). In particular, if an allergic reaction was observed during the injection of gadobutrol performed for care during the acute phase MRI a few hours or days before. * Patient benefiting from a legal protection measure * Pregnant or breastfeeding woman
Where it's running
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Hôpital Fondation Adolphe de Rothschild
Paris, France Recruiting
Study contacts
- Study coordinator: Jean-Philippe DESILLE, Pr
- Email: jpdesilles@for.paris
- Phone: + 33 1 48 03 69 13
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.