Predictive Multimodal MRI Factors in Subacute Cerebral Artery Occlusiontreated by Thrombectomy (PIMISUTT)

Not Applicable

Recruiting

• Conditions: Middle Cerebral Artery Acute Ischemic Stroke
• Interventions: Other: Multimodal MRI

• Registration Number: NCT04651010
• Lead Sponsor: Poitiers University Hospital

Brief Summary

Our study aims to measure metabolic and functional parameters of the infarcted territory by multimodal cerebral MRI in patients diagnosed with unilateral proximal occlusion of the middle cerebral artery and treated by thrombectomy in order to correlate those parameters to clinical outcome (evaluated by modified Rankin score) at 3 months.

We aim to find early radiologic predictive factors for favorable clinical outcome in this population of patients.

Detailed Description

The treatment of acute ischemic stroke in the setting of intracranial large artery occlusion and especially middle cerebral artery occlusion (MCAO) with intravenous tissue plasminogen activator (IV-tPA) is associated with low rates of recanalization and high rates of neurological morbidity and functional dependence.

In the last few years, endovascular intervention (mechanical thrombectomy) has proven its safety and its efficacy on clinical outcome in patients diagnosed with MCAO and is now commonly recommended.

However, in this population of patients treated by thrombectomy, very few predictive factors, except for the post-procedural recanalization score (TICI), do exist to foresee the variability of clinical outcome.

Tissue viability of the infarcted territory can be approached by the measure of metabolic and morphological parameters (Na+, H+, phosphore, diffusion imaging) which can be non-invasively done by multimodal MRI, as suggest by recently published studies.

Our study plans to measure these parameters between 12 and 24 hours after acute ischemic stroke in patients with MCAO treated by thrombectomy in order to correlate those parameters to clinical outcome at 3 months (modifier Rankin Score).

Study Timeline

• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-11-25
• Study First Posted: 2020-12-03
• Study Start: 2021-11-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2025-08-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients aged ≥ 18 years old
• Hospitalized at the Poitiers University Hospital
• Acute middle cerebral artery occlusion diagnosed by CT-scan or MRI
• NIHSS score ≥ 6 at admission
• To be treated by thrombectomy with or without fibrinolysis
• Written information delivered to the patient or his relatives concerning the study and its benefit and risk

Exclusion Criteria

• Patients or relatives whom a loyal information about the study cannot be given
• Patient with cognitive impairments before MRI.
• Patients who cannot undergo MRI because of contraindications
• Patients too deteriorated to tolerate one hour long exam

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multimodal MRI	Multimodal MRI	-

Primary Outcome Measures

Name	Time	Method
Correlation between modified Rankin score at 3 months and multimodal MRI data	Month 3

Secondary Outcome Measures

Name	Time	Method
Change in NIHSS score at 3 months compared to post-thrombectomy	Month 3
Discharge National Institute of Health Stroke Score (NIHSS)	Month 3
National Institute of Health Stroke (NIHSS) score at 3 months	Month 3

Trial Locations

Locations (1)

CHU Poitiers; 🇫🇷 Poitiers, France