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Medico-Economic Evaluation of MRI Versus CT as Diagnostic Imaging Strategies in Patients With Suspected Ischemic Stroke: the MAGRITTE Study.

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07719374
Acronym
MAGRITTE
Enrollment
600
Registered
2026-07-22
Start date
2026-09-01
Completion date
2030-09-01
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Computed tomography (CT), Magnetic resonance imaging (MRI), Cost-effectiveness

Brief summary

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_TESTCT 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_TESTMRI 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.

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK
Université Paris Descartes- Laboratoire Interdisciplinaire de Recherche Appliquée en Économie-Gestion et Santé - LIRAES
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Incremental cost per quality-adjusted life year (QALY) gained at 12 months12 months after stroke onset

Contacts

CONTACTMikael Mazighi, MD PhD
mmazighi@for.paris+33148036333

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026