Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease (MyRIAD)
The objective of this study is to determine the mechanisms of stroke in patients with Intracranial Atherosclerotic Disease (IAD) by specifically evaluating limitations of antegrade flow through the stenotic artery, distal tissue perfusion to the affected territory, and artery-to-artery embolism. The hypothesis is that non-invasive imaging biomarkers that stratify stroke risk and distinguish mechanisms of IAD. This prospective multicenter study will enroll 175 patients with recently symptomatic high-grade IAD. Patients will be studied within 21 days of the index event (allowing appropriate time to arrange for diverse imaging modalities), with the following advanced neuroimaging techniques to elucidate mechanisms of recurrent ischemia:
- Quantitative magnetic resonance imaging (QMRA) to assess volumetric flow rate through the stenotic artery.
- Magnetic resonance perfusion weighted imaging (PWI-MRI) to determine distal tissue perfusion.
- Vasomotor reactivity by Transcranial Doppler using the breath-holding technique (BHI-TCD) to assess compensatory flow characteristics to the territory distal to the affected artery;
- Transcranial Doppler with embolic signal monitoring to evaluate artery-to-artery embolism that reflects plaque instability.
Patients will receive standardized medical management and its effectiveness on blood pressure, lipid, and glycemic control will be monitored.
The primary outcome is recurrent stroke in the territory of the stenotic artery during a 1-year follow-up period; secondary outcomes are: a) new asymptomatic ischemic lesions on MRI in the distribution of the stenotic artery at 6-8 weeks, and b) transient ischemic attack (TIA) in the distribution of the stenotic artery during a 1-year follow-up period.
Patients will be recruited at various sites that will be trained and certified on the imaging techniques employed. Raw imaging data will be interpreted centrally.
調査の概要
状態
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35294
- University of Alabama at Birmingham
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California
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Los Angeles、California、アメリカ、90095
- UCLA
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Florida
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Gainesville、Florida、アメリカ、32611
- University of Florida
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Jacksonville、Florida、アメリカ、32224
- Mayo Clinic Jacksonville
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Miami、Florida、アメリカ、33136
- University of Miami
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Illinois
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Chicago、Illinois、アメリカ、60612
- Rush University Medical Center
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Chicago、Illinois、アメリカ、60611
- Northwestern University Department of Radiology
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New York
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New York、New York、アメリカ、10032
- Columbia University Medical Center
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- Medical University of South Carolina
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Texas
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Dallas、Texas、アメリカ、75390
- The University of Texas Southwestern Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Stroke defined as symptoms lasting >24 hours and associated with imaging evidence of acute ischemia in the distribution of the stenotic vessel on CT or MRI.
Eligible TIA defined as transient neurological symptoms lasting <24 hours, need to be:
- accompanied by DWI abnormalities in the distribution of the stenotic artery; or
- multiple (≥2), stereotyped events associated with unequivocal ischemic symptoms (weakness, aphasia), and attributed to the symptomatic artery.
- IAD should involve the intracranial carotid, middle cerebral, intracranial vertebral or basilar arteries.
Stenosis 50-99% quantified by digital subtraction angiography (DSA), CT angiography-CTA or MR angiography-MRA tests. DSA is not required but will be used if obtained as part of clinical care.
The criteria for 50-99% are:
- CTA or DSA: measured 50-99% stenosis by WASID criteria (percent stenosis = (1-[diameter stenosis/diameter normal]) x 100%.
- MRA: measured 50-99% stenosis or presence of a flow gap.
- Age >30; those 30-49 years of age must also have the presence of established atherosclerotic disease in another vascular bed (coronary, extracranial carotid, peripheral) or the presence of 2 or more risk factors (hypertension, diabetes mellitus, hyperlipidemia, tobacco abuse within the last 2 years).
- Enrollment within 21 days of symptom onset and completion of study imaging tests within 21 days of index event (stroke or TIA).
- Provide informed consent for participation in the study.
Exclusion Criteria:
- Other cause for stroke: atrial fibrillation, acute anterior wall ST-elevation myocardial infarction <30days, mitral stenosis, mechanical valve, intracardiac thrombus or vegetation, dilated cardiomyopathy or ejection fraction <30%, proximal extracranial carotid or vertebral stenosis >50%.
- Contraindications to MRI, including MR-incompatible metallic implants, implanted electronic devices, other potentially mobile ferromagnetic material, pregnancy (women in fertile age should have a negative pregnancy test), lactation, morbid obesity, and severe claustrophobia.
- Renal impairment defined as either a creatinine level >1.5 mg/dL or a glomerular filtration rate (GFR) <30 mL/min/1.73 m2.
- Known allergy to gadolinium.
- Unable to obtain informed consent by patient or legally authorized representative.
- Severe behavioral or social problems that may interfere with the conduct of the study.
- In the investigator's opinion, patient unlikely return for follow up visit and to complete the study.
- Participation in a drug or device clinical trial within the last 30 days.
研究計画
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 |
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Intracranial Atherosclerotic Disease, Stroke/TIA
Stroke/TIA due to high grade IAD ≤21 days from symptom onset.
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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 |
|---|---|---|
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Recurrent stroke in the territory of the symptomatic artery
時間枠：1 year
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Time to ischemic stroke in the territory of the symptomatic artery.
Stroke is ascertained by the site neurologist and defined as new or worsening symptoms lasting >24 hours and associated with imaging evidence of ischemia on CT or MRI in the distribution of the stenotic artery.
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1 year
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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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TIA in the territory of the stenotic artery
時間枠：1 year
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TIA in the territory of the stenotic artery is defined as transient neurological symptoms lasting <24 hours and clearly related to the stenotic artery as per a neurologist.
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1 year
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Silent infarcts in the distribution of the stenotic artery
時間枠：6-8 weeks
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Silent infarcts will be assessed by comparing the DWI and FLAIR sequences at baseline and at 6-8 weeks.
Silent infarcts are defined as new discrete lesions not apparent in the baseline images that are in the distribution of the stenotic artery, in the absence of the primary endpoint.
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6-8 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Risk of combined microembolic signals and impaired vasomotor reactivity.
時間枠：1 year
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Assess the interaction of the presence of micro embolic signals, assessed by TCD and a marker of plaque emboligenecity, and impaired vasomotor reactivity, assessed by TCD and a marker of collateral flow limitation, in increasing the risk of recurrent stroke in the territory of the target artery.
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1 year
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Risk of combined poor ante grade flow and poor distal tissue perfusion.
時間枠：1 year
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Assess the Interaction between two mechanisms of cerebral ischemia, poor antegrade flow assessed by quantitative MRA as a marker of flow across a stenotic arterial segment, and poor tissue perfusion assessed by perfusion MRI and representative of distal territorial perfusion, in the risk of recurrent stroke in the territory of the stenotic artery.
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1 year
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：David S Liebeskind, MD、University of California, Los Angeles
- 主任研究者：Jose G Romano, MD、University of Miami
- 主任研究者：Shyam Prabhakaran, MD、University of Chicago
出版物と役立つリンク
一般刊行物
- Prabhakaran S, Liebeskind DS, Cotsonis G, Nizam A, Feldmann E, Sangha RS, Campo-Bustillo I, Romano JG; MYRIAD Investigators. Predictors of Early Infarct Recurrence in Patients With Symptomatic Intracranial Atherosclerotic Disease. Stroke. 2021 Jun;52(6):1961-1966. doi: 10.1161/STROKEAHA.120.032676. Epub 2021 Apr 19.
- Romano JG, Prabhakaran S, Nizam A, Feldmann E, Sangha R, Cotsonis G, Campo-Bustillo I, Koch S, Rundek T, Chimowitz MI, Liebeskind DS; MyRIAD Investigators. Infarct Recurrence in Intracranial Atherosclerosis: Results from the MyRIAD Study. J Stroke Cerebrovasc Dis. 2021 Feb;30(2):105504. doi: 10.1016/j.jstrokecerebrovasdis.2020.105504. Epub 2020 Dec 1.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。