NCT03084523CompletedPhase 1
Treatment Targets for Inflamed Intracranial Atherosclerosis on Vessel Wall MRI
Source: ClinicalTrials.gov · Last updated 12 Sept 2025
Brief summary (registry, in English)
Intracranial atherosclerosis (ICAS) accounts for 10 to 40%, depending on ethnicity, of the 700,000 ischemic strokes in the United States every year. The annual rate of recurrent stroke in patients with optimally treated ICAS remains more than twice the average of other stroke etiologies (12.5% vs. 5). A robust literature has established that vessel wall magnetic resonance imaging (vwMRI) of extracranial carotid vessel wall enhancement (VWE) can predict stroke, independent of stenosis. VWE has been reported in symptomatic ICAS, but the role of local and systemic inflammation is unknown. Inflammatory biomarkers are elevated in symptomatic extracranial atherosclerosis, but the association with vwMRI findings in ICAS has not yet been explored. VWE is typically demonstrated by the uptake of gadolinium MRI contrast into the aneurysm wall or atherosclerotic plaque. A novel MRI contrast agent, ferumoxytol, allows multi-contrast weighting on T1w and T2w images and provides important insight into the role of local vessel wall inflammation by accumulating in macrophages on delayed T2\* sequences. To identify effective prevention and treatment strategies for cerebrovascular disease, we need to critically evaluate vwMRI techniques, determine VWE prevalence, and explore the link between VWE and inflammation.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 1 Feb 2017
- Start date
- 26 Apr 2017
- Primary completion date
- 3 Jun 2024
- Lead sponsor
- Yale University
- Diseases
- Stroke
- NCT number
- NCT03084523
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 30
- From 26 Apr 2017 to the primary completion date, 3 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 80 patients will be enrolled in this prospective cross-sectional study of Intracranial atherosclerosis.
- Inclusion Criteria:
- intracranial atherosclerosis (stenosis ≥50%)
- recent ischemic stroke (less than or equal to 14 days)
- Exclusion Criteria:
- Less than 18 years old
- Documented history of atrial fibrillation
- Carotid stenosis greater than 70%
- Pregnant women
- Contrast allergy
- Acute or chronic kidney disease with glomerular filtration rate\<30 ml/min/1.73m2
- Intravenous iron sensitivity
- Serum ferritin and transferrin saturation above age-adjusted upper limit of normal. If serum ferritin is above normal, but transferrin saturation is normal, the patient is not excluded.
- Pacemaker or other MRI contraindications
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.