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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Middle Cerebral Artery Acute Ischemic Stroke
• Intervention / Treatment: Other: Multimodal MRI

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume HERPE, Dr; Phone Number: 05 49 44 33 89; Email: guillaume.herpe@chu-poitiers.fr
• Study Contact Backup: Name: Céline DELETAGE; Phone Number: +33 05 49 44 38 54; Email: celine.deletage@chu-poitiers.fr

Study Locations

• France
  • Poitiers, France
    • Recruiting
    • CHU Poitiers
    • Contact: Guillaume HERPE, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Multimodal MRI	Other: Multimodal MRI; Multimodal MRI will be realized between 12 and 24 hours after thrombectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation between modified Rankin score at 3 months and multimodal MRI data	Month 3

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2021
• Primary Completion (ANTICIPATED): August 15, 2025
• Study Completion (ANTICIPATED): August 15, 2025

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (ACTUAL): December 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Ischemic stroke; thrombectomy; acute middle cerebral artery occlusion; multimodal MRI
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: PIMISUTT; 2020-A021118-31 (REGISTRY: ID-RBC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No