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

Middle Cerebral Artery Acute Ischemic Stroke Clinical Trial

— PIMISUTT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04651010
• Other study ID #: PIMISUTT
• Secondary ID: 2020-A021118-31
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: August 15, 2025

Study information

• Verified date: February 2023
• Source: Poitiers University Hospital
• Contact: Guillaume HERPE, Dr
• Phone: 05 49 44 33 89
• Email: guillaume.herpe[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 15, 2025
• Est. primary completion date: August 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• 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

Related Conditions & MeSH terms

• Ischemic Stroke
• Middle Cerebral Artery Acute Ischemic Stroke

Intervention

Other:
• Multimodal MRI
Multimodal MRI will be realized between 12 and 24 hours after thrombectomy

Locations

Country	Name	City	State
France	CHU Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between modified Rankin score at 3 months and multimodal MRI data		Month 3
Secondary	Discharge National Institute of Health Stroke Score (NIHSS)		Month 3
Secondary	National Institute of Health Stroke (NIHSS) score at 3 months		Month 3
Secondary	Change in NIHSS score at 3 months compared to post-thrombectomy		Month 3