- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07719374
Medico-Economic Evaluation of MRI Versus CT as Diagnostic Imaging Strategies in Patients With Suspected Ischemic Stroke: the MAGRITTE Study. (MAGRITTE)
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.
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Mikael Mazighi, MD PhD
- Telefonnummer: +33148036333
- E-post: mmazighi@for.paris
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: First-line non-contrast CT and CT angiography for suspected acute ischemic stroke.
|
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.
|
|
Aktiv komparator: First-line brain MRI and MR angiography for suspected acute ischemic stroke.
|
Participants undergo first-line brain magnetic resonance imaging (MRI) and MR angiography (MRA) for the evaluation of suspected acute ischemic stroke.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Incremental cost per quality-adjusted life year (QALY) gained at 12 months
Tidsramme: 12 months after stroke onset
|
12 months after stroke onset
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Slag
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Tomografi
- Diagnostisk avbildning
- Diagnostiske teknikker, kardiovaskulær
- Radiografi
- Angiografi
- Bildetolkning, datamaskinassistert
- Radiografisk bildeforbedring
- Bildeforbedring
- Fotografi
- Tomografi, røntgen
- Tomografi, røntgenberegnet
- Multimodal avbildning
- Magnetisk resonansavbildning
- Computed Tomography Angiography
- Magnetic Resonance Angiography
Andre studie-ID-numre
- MMI-2025-5
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