Radiohistological Correlation of Thrombohemorrhagic Remodeling in the Acute Phase of Ischemic Stroke Managed by Decompressive Hemicraniectomy

Acute Ischemic Stroke Clinical Trial

— SWI-SURGERY  

Official title:

Radiohistological Correlation of Thrombohemorrhagic Remodeling in the Acute Phase of Ischemic Stroke Managed by Decompressive Hemicraniectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05847699
• Other study ID #: JDS_2023_1
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: September 2025

Study information

• Verified date: December 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Recent years have witnessed a change in the therapeutic paradigm of stroke with the advent of mechanical thrombectomy as the reference treatment.

However, despite the achievement of effective proximal recanalization in nearly 80% of patients, nearly half of these patients have an unfavorable functional outcome. Several causes can be mentioned, such as the extent of the initial ischemic damage, the occurrence of complications related to reperfusion treatments or the occurrence of thrombosis of the downstream microvascularization. The latter is a phenomenon that has been known and studied increasingly over the last twenty years. It is the result of multiple cellular remodeling following ischemia and at the origin of an endoluminal filling by platelets, inflammatory cells and fibrin. This phenomenon introduces the fundamental difference between recanalization, i.e. the removal of the obstruction by the thrombus, and reperfusion, which translates into a satisfactory supply of oxygen to the ischemic tissues and therefore the expected result of these treatments. However, not all recanalization is necessarily accompanied by reperfusion, which is the phenomenon of no-reflow. This last situation could be explained by downstream microvascular thrombosis. Studies have shown the interest of intravenous thrombolysis associated with mechanical thrombectomy to preserve this vascular bed and improve cerebral reperfusion. More recently, a study has also shown the value of adding intra-arterial thrombolysis after mechanical thrombectomy. Nevertheless, there is currently no clinical evidence of the reality and prognostic importance of downstream microvascular thrombosis.

Advances in imaging have allowed the development of susceptibility weighted imaging (SWI) sequences with millimeter resolution, allowing a precise study of vascular damage and the appearance of previously unseen remodeling. Among them, the existence of cortical or juxta-cortical microinfarcts whose remnographic characteristics differed by the presence of a SWI hyposignal. The hypothesis evoked is that of a hemorrhagic remodeling consecutive to the barrier rupture. However, in view of the pathophysiology explained so far and the hypointense character of the thrombi on the SWI sequences, these remodeling could in fact be not microbleeding but rather markers of thrombosis in the downstream microcirculation. MRI would allow to identify the presence and the importance of microvascular thrombosis and thus to bring arguments to specifically target this microvascular component, consequence of cerebral ischemia, by antithrombotic or thrombolytic treatments.

The objective of our project is therefore to carry out a study focused on a better description and understanding of cortical and basal ganglia SWI hyposignals with a histopathological correlation and with the clinical prognosis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years

• Managed for sylvian ischemic stroke

• Requiring brain MRI as part of the evaluation for possible decompressive hemicraniectomy (DH).

• 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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• MRI sequences and biopsies
Addition of a contrast injection and optimized SWI sequences during the pre-DH MRI examination performed as part of the care Addition of two 1x1 cm biopsy samples of cortex in two different non-functional ischemic areas, one of which is within the SWI hyposignal remodeling, during the DH. This will be a cold pial dissection without the use of coagulation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the amount of microvascular thrombosis between samples taken in areas of SWI hyposignal on MRI and those taken in SWI isosignal areas.	Vascular microthrombosis defined as % of vessels affected/mm2	Day 0