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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 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 30 participants.

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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.

Interventions

  • DRUG Ferumoxytol Injectable Product

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2017-04-26
Est. Completion 2024-06-03
Phase Phase 1

Sponsor

Yale University

1,492 total trials

What the Registry Record Tells You About NCT03084523

The ClinicalTrials.gov registry entry for NCT03084523 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Ferumoxytol Injectable Product is the first listed.

NCT03084523 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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