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Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease (MyRIAD)

26 de mayo de 2021 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Tipo de estudio

De observación

Inscripción (Actual)

105

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

30 años a 99 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Recurrent stroke in the territory of the symptomatic artery
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
TIA in the territory of the stenotic artery
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Risk of combined microembolic signals and impaired vasomotor reactivity.
Periodo de tiempo: 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.
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de mayo de 2015

Finalización primaria (Actual)

31 de julio de 2020

Finalización del estudio (Actual)

31 de diciembre de 2020

Fechas de registro del estudio

Enviado por primera vez

18 de abril de 2014

Primero enviado que cumplió con los criterios de control de calidad

21 de abril de 2014

Publicado por primera vez (Estimar)

23 de abril de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de mayo de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

26 de mayo de 2021

Última verificación

1 de mayo de 2021

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Intracranial Vascular Disorders

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