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Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease (MyRIAD)

This study is currently recruiting participants.
Verified September 2017 by Jose Romano, MD, University of Miami
Sponsor:
ClinicalTrials.gov Identifier:
NCT02121028
First Posted: April 23, 2014
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of California, Los Angeles
Northwestern University
Emory University
Baystate Medical Center
Information provided by (Responsible Party):
Jose Romano, MD, University of Miami
  Purpose

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.


Condition
Intracranial Vascular Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease

Further study details as provided by Jose Romano, MD, University of Miami:

Primary Outcome Measures:
  • Recurrent stroke in the territory of the symptomatic artery [ Time Frame: 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.


Secondary Outcome Measures:
  • TIA in the territory of the stenotic artery [ Time Frame: 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.

  • Silent infarcts in the distribution of the stenotic artery [ Time Frame: 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.


Other Outcome Measures:
  • Risk of combined microembolic signals and impaired vasomotor reactivity. [ Time Frame: 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.

  • Risk of combined poor ante grade flow and poor distal tissue perfusion. [ Time Frame: 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.


Estimated Enrollment: 175
Study Start Date: January 2015
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts
Intracranial Atherosclerotic Disease, Stroke/TIA
Stroke/TIA due to high grade IAD ≤21 days from symptom onset.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients will have a recent stroke or TIA due to intracranial Atherosclerotic Disease (IAD) of 50-99% .
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02121028


Contacts
Contact: Jose G Romano, MD 305-243-8018 jromano@med.miami.edu
Contact: Iszet C Bustillo, MD, MPH 305-243-8018 icampo@med.miami.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Mark Harrigan, MD    205-934-3131    mharrigan@uabmc.edu   
Contact: Lisa Nelson, RN    205-934-3131    lnelson@uabmc.edu   
United States, California
UCLA Recruiting
Los Angeles, California, United States, 90095
Contact: David S Liebeskind, MD    310-963-5539    davidliebeskind@yahoo.com   
Contact: Graham Woolf    310.963.5539    gwoolf75@gmail.com   
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Anna Khanna, MD    352-273-5550    anna.khanna@neurology.ufl.edu   
Contact: Sonisha A Warren, PhD    352-273-5575    Sonisha.Warren@neurology.ufl.edu   
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Josephine Huang, MD    904-953-0302      
Contact: Susan Melton    904-953-8927      
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Iszet C Bustillo, MPH    305-243-8018    icampo@med.miami.edu   
Principal Investigator: Jose G Romano, MD         
United States, Illinois
Northwestern University Department of Radiology Recruiting
Chicago, Illinois, United States, 60611
Contact: Sameer Ansari, MD    312-695-0689    sansari@nm.org   
Contact: Ayesha Muzaffar    312-926-4251    ayesha.muzaffar@northwestern.edu   
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Sarah Y Song, MD    312-563-2208    Sarah_Song@rush.edu   
Contact: Tiffany Singson    312-563-2208    Tiffany_Singson@rush.edu   
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Mitchell S Elkind, MD    212-305-1710    mse13@cumc.columbia.edu   
Contact: Rebeca Aragon Garcia    212 305-7755    ra2356@cumc.columbia.edu   
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Tanya Turan, MD    843-792-9796    turan@musc.edu   
Contact: Todd LeMatty    843-792-9796    lematty@musc.edu   
United States, Texas
The University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Mark Johnson, MD    214-648-7811    Mark.Johnson@UTSouthwestern.edu   
Contact: Jan Cameron-Watts, RN    214-648-0363    Jan.CameronWatts@UTSouthwestern.edu   
Sponsors and Collaborators
University of Miami
University of California, Los Angeles
Northwestern University
Emory University
Baystate Medical Center
Investigators
Principal Investigator: Jose G Romano, MD University of Miami
Principal Investigator: Shyam Prabhakaran, MD Northwestern University
Principal Investigator: David S Liebeskind, MD University of California, Los Angeles
  More Information

Responsible Party: Jose Romano, MD, Professor of Clinical Neurology, University of Miami
ClinicalTrials.gov Identifier: NCT02121028     History of Changes
Other Study ID Numbers: 20140056
First Submitted: April 18, 2014
First Posted: April 23, 2014
Last Update Posted: September 26, 2017
Last Verified: September 2017

Keywords provided by Jose Romano, MD, University of Miami:
Intracranial Atherosclerotic Disease
Stroke
Transient Ischemic Attack
Imaging

Additional relevant MeSH terms:
Recurrence
Vascular Diseases
Cerebrovascular Disorders
Disease Attributes
Pathologic Processes
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases