Medico-Economic Evaluation of MRI Versus CT as Diagnostic Imaging Strategies in Patients With Suspected Ischemic Stroke: A Prospective, Multicenter, Randomized Controlled Two-Arm Parallel Trial.
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: CT and CT angiography (CTA), MRI and MR angiography (MRA).
- Who it may be relevant to
- Registry conditions: 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
- Center list to be confirmed — check the primary protocol.
- 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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Overview
Acute ischemic stroke (AIS) is a leading cause of death and long-term disability worldwide. In patients with suspected large vessel occlusion, rapid diagnosis and reperfusion therapy are critical, as treatment delays are associated with worse functional outcomes and increased mortality. Current French guidelines recommend brain magnetic resonance imaging (MRI) as the reference imaging modality because of its high diagnostic accuracy. However, MRI availability remains limited in many stroke centers, often resulting in delays in diagnosis and treatment. Conversely, computed tomography (CT) is more widely available and can substantially shorten time to reperfusion, although it may be less sensitive for early ischemic changes. The MAGRITTE study aims to determine whether an initial CT-based imaging strategy is more cost-effective than an MRI-based strategy for patients with suspected severe acute ischemic stroke within 6 hours of symptom onset. This is a prospective, multicenter, randomized controlled trial with two parallel groups enrolling 600 adult patients presenting with a high suspicion of acute ischemic stroke due to proximal large vessel occlusion (National Institutes of Health Stroke Scale \[NIHSS\] score ≥10). Participants will be randomized to undergo either CT with CT angiography or MRI with MR angiography as the first-line diagnostic imaging examination. Additional perfusion imaging may be performed at the investigator's discretion. The primary objective is to compare the cost-utility of the two diagnostic strategies at 12 months, expressed as the incremental cost per quality-adjusted life year (QALY) gained, using EQ-5D-5L-derived utilities. Secondary objectives include lifetime cost-effectiveness modeling, 5-year budget impact analysis, comparison of functional outcomes, mortality, imaging-to-treatment and reperfusion times, symptomatic intracranial hemorrhage, diagnostic accuracy, management pathways, adverse events, radiation exposure, and healthcare costs. The study will provide evidence on whether a CT-first imaging strategy can improve the efficiency of acute stroke care while maintaining favorable clinical outcomes and reducing healthcare costs.
Interventions
- Diagnostic test CT and CT angiography (CTA)
Participants randomized to this intervention undergo first-line non-contrast brain computed tomography (CT) and CT angiography (CTA) for the diagnosis of suspected acute ischemic stroke. - Diagnostic test MRI and MR angiography (MRA)
Participants undergo first-line brain magnetic resonance imaging (MRI) and MR angiography (MRA) for the evaluation of suspected acute ischemic stroke.
Primary outcome measures
- Incremental cost per quality-adjusted life year (QALY) gained at 12 months [Time frame: 12 months after stroke onset]
Eligibility criteria
Inclusion criteria
- Age ≥18 years
- Symptoms consistent with suspected acute ischemic stroke due to proximal large vessel occlusion
- National Institutes of Health Stroke Scale (NIHSS) score ≥10 at admission
- Symptom onset <6 hours before randomization
Exclusion criteria
- Previous diagnostic brain imaging performed within the preceding 24 hours for the index stroke event
- Contraindication to MRI (e.g., cardiac pacemaker, metallic implant or foreign body, surgical clips) or CT (e.g., pregnancy, severe renal impairment)
- Contraindication to iodinated contrast agent (e.g., known severe allergy)
- Not affiliated with the French national health insurance system
- Not residing in France
- Pregnant or breastfeeding
- Adults under legal protection
- Participation in another interventional clinical trial (RIPH1 or equivalent)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07719374 · MMI-2025-5