Ferumoxytol for Intracranial Atherosclerosis

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byAdam de Havenon, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Utah

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults who've had a recent ischemic stroke (within the last 14 days) and have significant intracranial artery narrowing (stenosis ≥50%). It's not suitable for those under 18, with atrial fibrillation history, severe carotid stenosis (>70%), pregnancy, contrast allergies, serious kidney issues, pacemaker or MRI contraindications, iron sensitivity or high ferritin/transferrin levels.

Inclusion Criteria

I have a significant narrowing in my brain's arteries.

I had a stroke less than 14 days ago.

Exclusion Criteria

You have a pacemaker or any other medical condition that makes it unsafe for you to have an MRI.

I have a documented history of atrial fibrillation.

I have a narrowing in my carotid artery of more than 70%.

+6 more

Participant Groups

The study tests Ferumoxytol Injectable Product as an MRI contrast agent to detect inflammation in brain arteries after a stroke. The goal is to understand if vessel wall enhancement on MRI can predict strokes by showing local inflammation within plaques in the brain's arteries.

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment1 Intervention

80 patients with intracranial atherosclerosis