Treatment Targets for Inflamed Intracranial Atherosclerosis on Vessel Wall MRI

• Status: Enrolling by invitation
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Cerebrovascular disease is a major source of neural injury and there is an urgent need for comprehensive evaluation of these patients. High-resolution MRI (HR-MRI) allows direct visualization of intracranial vessel wall pathology in the setting of acute ischemic stroke and intracranial aneurysm (intracranial aneurysm rupture.Vessel wall enhancement on HR-MRI results from inflammation and has considerable potential as a marker of future stroke risk or aneurysm rupture. We will use our HR-MRIvwMRI protocol and other techniques of measuring plaque and aneurysms vulnerability, including laboratory markers of abnormal inflammation and oxidization, which have been shown to correlate with vulnerable carotid atherosclerosis and intracranial aneurysms, but have not been studied in symptomatic ICAS or IA.The unmet need is a study validating HR-MRI reliability and the association of vessel-wall enhancement with both symptomatic and pro-inflammatory status in patients with cerebrovascular disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: AMAG Pharmaceuticals, Inc.
• Treatments: Ferrosoferric Oxide

Criteria

80 patients will be enrolled in this prospective cross-sectional study of 2 cohorts:(A) Intracranial atherosclerosis & (B) Intracranial aneurysms

• Inclusion Criteria:

• (A) cohort: 60 intracranial atherosclerosis (stenosis less than 25%)

• recent ischemic stroke (less than or equal to 14 days)

• (B) cohort: 20 intracranial aneurysms patients participants:

• 10 asymptomatic

• 10 with recent intracranial aneurysm(s) rupture (less than or equal to 7 days).

• Exclusion Criteria:

• Less than 18 years old

• Documented history of atrial fibrillation (for intracranial atherosclerosis cohort).

• Carotid stenosis greater than 70% (for intracranial atherosclerosis cohort).

• 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