Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease
Public ClinicalTrials.gov record NCT02121028. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02121028
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 105 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 30 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 1, 2015 (Actual)
- Primary completion
- Jul 31, 2020 (Actual)
- Completion
- Dec 31, 2020 (Actual)
- Last update posted
- May 28, 2021
2015 – 2020
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| UCLA | Los Angeles | California | 90095 | — |
| University of Florida | Gainesville | Florida | 32611 | — |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Northwestern University Department of Radiology | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02121028, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 28, 2021 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02121028 live on ClinicalTrials.gov.