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Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease (MyRIAD)

26. maj 2021 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

105

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham
    • California
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA
    • Florida
      • Gainesville, Florida, Forenede Stater, 32611
        • University of Florida
      • Jacksonville, Florida, Forenede Stater, 32224
        • Mayo Clinic Jacksonville
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University Department of Radiology
    • New York
      • New York, New York, Forenede Stater, 10032
        • Columbia University Medical Center
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, Forenede Stater, 75390
        • The University of Texas Southwestern Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

30 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Eligible patients will have a recent stroke or TIA due to intracranial Atherosclerotic Disease (IAD) of 50-99% .

Beskrivelse

Inclusion Criteria:

  1. 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.

  2. Eligible TIA defined as transient neurological symptoms lasting <24 hours, need to be:

    1. accompanied by DWI abnormalities in the distribution of the stenotic artery; or
    2. multiple (≥2), stereotyped events associated with unequivocal ischemic symptoms (weakness, aphasia), and attributed to the symptomatic artery.
  3. IAD should involve the intracranial carotid, middle cerebral, intracranial vertebral or basilar arteries.

  4. 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:

    1. CTA or DSA: measured 50-99% stenosis by WASID criteria (percent stenosis = (1-[diameter stenosis/diameter normal]) x 100%.
    2. MRA: measured 50-99% stenosis or presence of a flow gap.
  5. 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).
  6. Enrollment within 21 days of symptom onset and completion of study imaging tests within 21 days of index event (stroke or TIA).
  7. Provide informed consent for participation in the study.

Exclusion Criteria:

  1. 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%.
  2. 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.
  3. Renal impairment defined as either a creatinine level >1.5 mg/dL or a glomerular filtration rate (GFR) <30 mL/min/1.73 m2.
  4. Known allergy to gadolinium.
  5. Unable to obtain informed consent by patient or legally authorized representative.
  6. Severe behavioral or social problems that may interfere with the conduct of the study.
  7. In the investigator's opinion, patient unlikely return for follow up visit and to complete the study.
  8. Participation in a drug or device clinical trial within the last 30 days.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intracranial Atherosclerotic Disease, Stroke/TIA
Stroke/TIA due to high grade IAD ≤21 days from symptom onset.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recurrent stroke in the territory of the symptomatic artery
Tidsramme: 1 year
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.
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
TIA in the territory of the stenotic artery
Tidsramme: 1 year
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.
1 year
Silent infarcts in the distribution of the stenotic artery
Tidsramme: 6-8 weeks
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.
6-8 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Risk of combined microembolic signals and impaired vasomotor reactivity.
Tidsramme: 1 year
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.
1 year
Risk of combined poor ante grade flow and poor distal tissue perfusion.
Tidsramme: 1 year
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.
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Miami

Samarbejdspartnere

University of California, Los Angeles
Northwestern University
National Institute of Neurological Disorders and Stroke (NINDS)
Emory University
Baystate Medical Center

Efterforskere

  • Ledende efterforsker: David S Liebeskind, MD, University of California, Los Angeles
  • Ledende efterforsker: Jose G Romano, MD, University of Miami
  • Ledende efterforsker: Shyam Prabhakaran, MD, University of Chicago

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2015

Primær færdiggørelse (Faktiske)

31. juli 2020

Studieafslutning (Faktiske)

31. december 2020

Datoer for studieregistrering

Først indsendt

18. april 2014

Først indsendt, der opfyldte QC-kriterier

21. april 2014

Først opslået (Skøn)

23. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2021

Sidst verificeret

1. maj 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20140056
  • 1R01NS084288-01A1 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

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