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NCT02121028 · ClinicalTrials.gov registry record
Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease
A clinical trial of Intracranial Vascular Disorders, sponsored by University of Miami.
- Completed
- Registry status
- 105
- Enrollment target
- 10
- Study locations
NCT02121028: Completed study of Intracranial Vascular Disorders, sponsored by University of Miami.
NCT02121028 is a study of Intracranial Vascular Disorders that has completed, run by University of Miami. The registered enrollment target is 105 participants. The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02121028, a study of Intracranial Vascular Disorders, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- 105 participants
- Enrollment target
- 10
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Study Locations (10)
Florida
- University of Florida - Gainesville
- Mayo Clinic Jacksonville - Jacksonville
- University of Miami - Miami
Illinois
- Northwestern University Department of Radiology - Chicago
- Rush University Medical Center - Chicago
Alabama
- University of Alabama at Birmingham - Birmingham
California
- UCLA - Los Angeles
New York
- Columbia University Medical Center - New York
South Carolina
- Medical University of South Carolina - Charleston
Texas
- The University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2015-05-01 |
| Est. Completion | 2020-12-31 |
What the finished NCT02121028 record still lists
NCT02121028 is an observational study that tracks outcomes without assigning an intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Intracranial Vascular Disorders appearing as the primary indexed condition, and to 0 interventions.
NCT02121028 lists 10 locations in 7 states (Florida, Illinois, Alabama).
Frequently Asked Questions
What is clinical trial NCT02121028 about?
NCT02121028 is a clinical study titled "Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease". 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...
What is the current status of trial NCT02121028?
This trial is currently completed. The enrollment target is 105 participants. The study started on 2015-05-01. Estimated completion is 2020-12-31.
What conditions does trial NCT02121028 study?
This clinical trial studies the following conditions: Intracranial Vascular Disorders.
Who is sponsoring clinical trial NCT02121028?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02121028 being conducted?
This trial has 10 study locations across Alabama, California, Florida, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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