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NCT03084523 · ClinicalTrials.gov registry record · Phase 1
Treatment Targets for Inflamed Intracranial Atherosclerosis on Vessel Wall MRI
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03084523: Completed Phase 1 study, sponsored by Yale University.
NCT03084523 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03084523, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Both patient groups will have a high-resolution vessel wall enhancement-gadolinium MRI at baseline with a delayed high-resolution vessel wall enhancement-Ferumoxytol MRI. Prevalence will be analyzed between the different participants in each group. Hypothesis: Participants with intracranial atherosclerosis will have a high prevalence of vessel wall enhancement.
Interventions
- DRUG Ferumoxytol Injectable Product
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-04-26 |
| Est. Completion | 2024-06-03 |
| Phase | Phase 1 |
What the finished NCT03084523 record still lists
NCT03084523 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Ferumoxytol Injectable Product is the first listed.
NCT03084523 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03084523 about?
NCT03084523 is a clinical study titled "Treatment Targets for Inflamed Intracranial Atherosclerosis on Vessel Wall MRI". 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...
What is the current status of trial NCT03084523?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2017-04-26. Estimated completion is 2024-06-03.
What interventions are being tested in trial NCT03084523?
The interventions under investigation include: Ferumoxytol Injectable Product (DRUG).
Who is sponsoring clinical trial NCT03084523?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03084523's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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