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Recruiting NCT04651010

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

No phase Interventional Middle Cerebral Artery Acute Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multimodal MRI.
Who it may be relevant to
Registry conditions: Middle Cerebral Artery Acute Ischemic Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Correlation between modified Rankin score at 3 months and multimodal MRI data [Time frame: Month 3]
Secondary outcome measures (3)
  • Discharge National Institute of Health Stroke Score (NIHSS) [Time frame: Month 3]
  • National Institute of Health Stroke (NIHSS) score at 3 months [Time frame: Month 3]
  • Change in NIHSS score at 3 months compared to post-thrombectomy [Time frame: Month 3]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

France · 1 center
  • CHU Poitiers — Poitiers

Identifiers

NCT: NCT04651010 · PIMISUTT · 2020-A021118-31

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗