MRI plus tissue analysis to understand clot-related bleeding and microvascular blockage after large sylvian ischemic stroke treated with hemicraniectomy
Radiohistological Correlation of Thrombohemorrhagic Remodeling in the Acute Phase of Ischemic Stroke Managed by Decompressive Hemicraniectomy
NA · Fondation Ophtalmologique Adolphe de Rothschild · NCT05847699
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild (network) |
| Locations | 1 site (Paris) |
| Trial ID | NCT05847699 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Paris
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Ischemic Stroke