StrokeMAGRITTENCT07719374
Medico-Economic Evaluation of MRI Versus CT as Diagnostic Imaging Strategies in Patients With Suspected Ischemic Stroke: the MAGRITTE Study.
A study testing CT and CT angiography (CTA) and MRI and MR angiography (MRA) in people with Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- CT and CT angiography (CTA) and MRI and MR angiography (MRA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
- Conditions
- Stroke
- Being tested
- CT and CT angiography (CTA), MRI and MR angiography (MRA)
- Keywords
- Stroke, Computed tomography (CT), Magnetic resonance imaging (MRI), Cost-effectiveness
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT and CT angiography (CTA)Diagnostic test
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.
MRI and MR angiography (MRA)Diagnostic test
Participants undergo first-line brain magnetic resonance imaging (MRI) and MR angiography (MRA) for the evaluation of suspected acute ischemic stroke.
| Study group | Role | What they receive |
|---|---|---|
| First-line non-contrast CT and CT angiography for suspected acute ischemic stroke. | Experimental | Not described Receives: Diagnostic Test: CT and CT angiography (CTA) |
| First-line brain MRI and MR angiography for suspected acute ischemic stroke. | Active comparator | Not described Receives: Diagnostic Test: MRI and MR angiography (MRA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental cost per quality-adjusted life year (QALY) gained at 12 months
Measured: 12 months after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Collaborators
- Université Paris Descartes- Laboratoire Interdisciplinaire de Recherche Appliquée en Économie-Gestion et Santé - LIRAES
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719374
- Sponsor's protocol ID
- MMI-2025-5
- Acronym
- MAGRITTE
- Status last verified
- Nov 2026
- First submitted
- 17 Jul 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07719374
- Acronym / sponsor ID
- MAGRITTE / MMI-2025-5
- Conditions
- Stroke
- Keywords
- Stroke, Computed tomography (CT), Magnetic resonance imaging (MRI), Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Collaborators
- Université Paris Descartes- Laboratoire Interdisciplinaire de Recherche Appliquée en Économie-Gestion et Santé - LIRAES
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Sep 2030 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First-line non-contrast CT and CT angiography for suspected acute ischemic stroke. | Experimental | Diagnostic Test: CT and CT angiography (CTA) |
| First-line brain MRI and MR angiography for suspected acute ischemic stroke. | Active comparator | Diagnostic Test: MRI and MR angiography (MRA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | First-line non-contrast CT and CT angiography for suspected acute ischemic stroke. |
| 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. | Diagnostic test | First-line brain MRI and MR angiography for suspected acute ischemic stroke. |
Primary outcome
Incremental cost per quality-adjusted life year (QALY) gained at 12 months
Time frame: 12 months after stroke onset
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing CT and CT angiography (CTA) and MRI and MR angiography (MRA) in people with Stroke, run by Fondation Ophtalmologique Adolphe de Rothschild.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikael Mazighi, MD PhD (+33148036333, mmazighi@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental cost per quality-adjusted life year (QALY) gained at 12 months (time frame: 12 months after stroke onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.