Low-Field MRI in Stroke Code Patients (LFMIS)
2026年7月14日 更新者：Nyika D. Kruyt、Leiden University Medical Center
Validation of Low Field MRI in Patients With Stroke Symptoms Less Than 12 Hours
This study evaluates the accuracy and feasibility of a portable low-field MRI (Hyperfine) device in patients presenting to the emergency department with suspected acute stroke.
All enrolled patients undergo standard clinical imaging (CT, CT angiography, CT perfusion) and additionally receive a low-field MRI scan.
Low-field MRI findings are compared to routine CT imaging and final clinical diagnosis.
The study aims to determine whether low-field MRI can reliably detect acute ischemic stroke (including lacunar and large vessel occlusion), hemorrhagic stroke, and stroke mimics in the acute setting.
Secondary outcomes include feasibility measures such as scan time, completion rate, patient satisfaction, and adverse events.
調査の概要
研究の種類
観察的
入学 (推定)
80
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Nyika Kruyt, MD, PhD
- 電話番号：+31 71 526 9111
- メール：n.d.kruyt@lumc.nl
研究連絡先のバックアップ
- 名前：Robert Croese
- メール：r.j.i.croese@lumc.nl
研究場所
-
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South Holland
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Leiden、South Holland、オランダ、2333ZA
- 募集
- Leiden University Medical Center
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Adult patients presenting to the emergency department of a tertiary academic hospital (LUMC) with suspected acute stroke (stroke code activation) within 12 hours of symptom onset.
The study population includes patients with ischemic stroke (large vessel occlusion and lacunar), hemorrhagic stroke, and stroke mimics, reflecting real-world acute stroke diagnostics.
説明
Inclusion Criteria:
- Age ≥ 18 years
- Presentation with suspected acute stroke (stroke code activation by ambulance paramedics)
- Symptom onset < 12 hours prior to presentation
- Admission to the emergency department of the Leiden University Medical Center (LUMC) during office hours
- Undergoing standard-of-care head CT imaging at the emergency department
- Ability to provide informed consent (written or verbal in the acute setting, with deferred written consent if applicable)
Exclusion Criteria:
- Imminent death
- Severe claustrophobia preventing MRI
- Presence of MRI-incompatible implanted devices (e.g., pacemaker, cochlear implant, insulin pump)
- Known intra-ocular metallic foreign body or intracranial metallic clip/device identified on admission CT
- Pregnancy
- Acute life-threatening or disabling condition requiring immediate intervention that precludes study procedures
- Any study-related delay that could interfere with time-critical stroke treatments (intravenous thrombolysis or endovascular thrombectomy)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Ischemic stroke - lacunar infarct
Patients with clinical and radiological suspicion of lacunar ischemic stroke (subcortical infarct).
These patients often receive additional conventional MRI during routine work-up for radiological confirmation.
All patients undergo low-field MRI scanning in addition to routine clinical imaging.
|
Low-field MRI (Hyperfine Swoop, 0.064 Tesla) is performed once, in addition to routine clinical imaging (non-contrast CT, CT angiography, and CT perfusion as clinically indicated).
The scan is acquired after routine imaging and after initial treatment decisions, during office hours, with the patient on their ED bed.
Scan duration and any interruptions are recorded.
|
|
Hemorrhagic stroke
Patients with hemorrhagic stroke (intracerebral hemorrhage) demonstrated on non-contrast CT at the emergency department.
All patients undergo low-field MRI scanning in addition to routine clinical imaging.
|
Low-field MRI (Hyperfine Swoop, 0.064 Tesla) is performed once, in addition to routine clinical imaging (non-contrast CT, CT angiography, and CT perfusion as clinically indicated).
The scan is acquired after routine imaging and after initial treatment decisions, during office hours, with the patient on their ED bed.
Scan duration and any interruptions are recorded.
|
|
Stroke mimic
Patients with non-stroke diagnosis based on clinical judgment and neuro-imaging at the emergency department (e.g., epilepsy, migraine, functional neurological disorder).
All patients undergo low-field MRI scanning in addition to routine clinical imaging.
|
Low-field MRI (Hyperfine Swoop, 0.064 Tesla) is performed once, in addition to routine clinical imaging (non-contrast CT, CT angiography, and CT perfusion as clinically indicated).
The scan is acquired after routine imaging and after initial treatment decisions, during office hours, with the patient on their ED bed.
Scan duration and any interruptions are recorded.
|
|
Ischemic stroke - proximal vessel occlusion
Patients with ischemic stroke due to proximal vessel occlusion in the anterior circulation (large vessel occlusion, LVO) diagnosed by CT angiography at the emergency department.
All patients in this group undergo low-field MRI scanning in addition to routine clinical imaging.
|
Low-field MRI (Hyperfine Swoop, 0.064 Tesla) is performed once, in addition to routine clinical imaging (non-contrast CT, CT angiography, and CT perfusion as clinically indicated).
The scan is acquired after routine imaging and after initial treatment decisions, during office hours, with the patient on their ED bed.
Scan duration and any interruptions are recorded.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diagnostic accuracy of low-field MRI for acute stroke detection
時間枠：At time of low-field MRI scan (within 12 hours of symptom onset)
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Sensitivity, specificity, positive predictive value, and negative predictive value of low-field MRI findings for detecting acute stroke (ischemic or hemorrhagic) and stroke mimics, using final clinical diagnosis at discharge as the reference standard.
Low-field MRI images are assessed by a neuroradiologist blinded to CT findings and final diagnosis.
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At time of low-field MRI scan (within 12 hours of symptom onset)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adverse events during low-field MRI scanning
時間枠：During low-field MRI scan and up to 30 minutes thereafter
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Number and type of adverse events (AEs) and serious adverse events (SAEs) occurring during the low-field MRI scanning procedure or within 30 minutes after completion.
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During low-field MRI scan and up to 30 minutes thereafter
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Patient satisfaction with low-field MRI procedure
時間枠：Within 24 hours after low-field MRI scan.
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Patient-reported satisfaction with the low-field MRI scanning experience, assessed using a structured questionnaire or verbal interview.
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Within 24 hours after low-field MRI scan.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Mazurek MH, Cahn BA, Yuen MM, Prabhat AM, Chavva IR, Shah JT, Crawford AL, Welch EB, Rothberg J, Sacolick L, Poole M, Wira C, Matouk CC, Ward A, Timario N, Leasure A, Beekman R, Peng TJ, Witsch J, Antonios JP, Falcone GJ, Gobeske KT, Petersen N, Schindler J, Sansing L, Gilmore EJ, Hwang DY, Kim JA, Malhotra A, Sze G, Rosen MS, Kimberly WT, Sheth KN. Portable, bedside, low-field magnetic resonance imaging for evaluation of intracerebral hemorrhage. Nat Commun. 2021 Aug 25;12(1):5119. doi: 10.1038/s41467-021-25441-6.
- Sheth KN, Mazurek MH, Yuen MM, Cahn BA, Shah JT, Ward A, Kim JA, Gilmore EJ, Falcone GJ, Petersen N, Gobeske KT, Kaddouh F, Hwang DY, Schindler J, Sansing L, Matouk C, Rothberg J, Sze G, Siner J, Rosen MS, Spudich S, Kimberly WT. Assessment of Brain Injury Using Portable, Low-Field Magnetic Resonance Imaging at the Bedside of Critically Ill Patients. JAMA Neurol. 2020 Sep 8;78(1):41-7. doi: 10.1001/jamaneurol.2020.3263. Online ahead of print.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年4月20日
一次修了 (推定)
2027年4月1日
研究の完了 (推定)
2027年8月1日
試験登録日
最初に提出
2026年7月3日
QC基準を満たした最初の提出物
2026年7月10日
最初の投稿 (実際)
2026年7月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月16日
QC基準を満たした最後の更新が送信されました
2026年7月14日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- NL87809.058.24
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Due to the limited sample size, the single-centre design, and privacy considerations under GDPR, there is no plan to share individual participant data.
Aggregate results will be published in peer-reviewed journals and presented at scientific meetings.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
はい
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。