Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease (MyRIAD)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02121028|
Recruitment Status : Active, not recruiting
First Posted : April 23, 2014
Last Update Posted : December 12, 2019
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 or disease|
|Intracranial Vascular Disorders|
|Study Type :||Observational|
|Estimated Enrollment :||175 participants|
|Official Title:||Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||February 2021|
Intracranial Atherosclerotic Disease, Stroke/TIA
Stroke/TIA due to high grade IAD ≤21 days from symptom onset.
- 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.
- 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.
- 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.
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
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|Los Angeles, California, United States, 90095|
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32611|
|Mayo Clinic Jacksonville|
|Jacksonville, Florida, United States, 32224|
|University of Miami|
|Miami, Florida, United States, 33136|
|United States, Illinois|
|Northwestern University Department of Radiology|
|Chicago, Illinois, United States, 60611|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Texas|
|The University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|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|