Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease (MyRIAD)
26 maj 2021 uppdaterad av: Jose Romano, MD, University of Miami
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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
105
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- University of Alabama at Birmingham
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California
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Los Angeles, California, Förenta staterna, 90095
- UCLA
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Florida
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Gainesville, Florida, Förenta staterna, 32611
- University of Florida
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Jacksonville, Florida, Förenta staterna, 32224
- Mayo Clinic Jacksonville
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Miami, Florida, Förenta staterna, 33136
- University of Miami
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Illinois
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Chicago, Illinois, Förenta staterna, 60612
- Rush University Medical Center
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern University Department of Radiology
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New York
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New York, New York, Förenta staterna, 10032
- Columbia University Medical Center
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29425
- Medical University of South Carolina
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Texas
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Dallas, Texas, Förenta staterna, 75390
- The University of Texas Southwestern Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
30 år till 99 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Eligible patients will have a recent stroke or TIA due to intracranial Atherosclerotic Disease (IAD) of 50-99% .
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Recurrent stroke in the territory of the symptomatic artery
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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TIA in the territory of the stenotic artery
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Risk of combined microembolic signals and impaired vasomotor reactivity.
Tidsram: 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.
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: David S Liebeskind, MD, University of California, Los Angeles
- Huvudutredare: Jose G Romano, MD, University of Miami
- Huvudutredare: Shyam Prabhakaran, MD, University of Chicago
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 maj 2015
Primärt slutförande (Faktisk)
31 juli 2020
Avslutad studie (Faktisk)
31 december 2020
Studieregistreringsdatum
Först inskickad
18 april 2014
Först inskickad som uppfyllde QC-kriterierna
21 april 2014
Första postat (Uppskatta)
23 april 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
28 maj 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 maj 2021
Senast verifierad
1 maj 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 20140056
- 1R01NS084288-01A1 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
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NEJ
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