Aspirin Attenuates Inflammation in Human Cerebral Aneurysms

Completed · Phase 1

Conditions studied: The Focus of the Study is to Monitor MRI Signal Changes and Inflammatory Biomarkers With Use of Aspirin in Patients With Unruptured Cerebral Aneurysm

In brief

Hypothesis: aspirin attenuates inflammation in cerebral aneurysms and hence reduces the incidence of rupture. This effect can be monitored using the signal generated by macrophages (inflammatory biomarker) in ferumoxytol-enhanced MRI. Study aims: 1\. Determine if daily aspirin intake (for three months) would obliterate/reduce ferumoxytol-enhanced MRI signal changes generated by macrophages in cerebral aneurysm wall. Fifteen patients with cerebral aneurysms \> 7 mm will be selected to enroll in this pilot study. 10 patients will be imaged at base line with ferumoxytol-enhanced MRI. Following that, they will take aspirin 81 mg daily and then re-imaged again at three months. This group will be compared to a control group of 5 patients where they will have the imagings studies performed at base line and at three months but will NOT take aspirin.

Key facts

Study ID

NCT01710072

Run by

University of Iowa

People needed

11

Starts

2011-08-01

Expected to finish

2014-08-01

Last updated by the study team

2015-05-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• age 18-80 years.
• Incidental (non-ruptured) IA ≥5 mm.
• Treating neurosurgeon and patient agree on observation period of 3 months before proceeding with treatment either endovascularly or by microsurgical clipping.
• Positive MRI signal change corresponding of ferumoxytol uptake is observed.
• No history of aspirin intake or NSAIDs for 4 weeks prior to enrolment.
• No current history of statin use.

You may not qualify if…

• Patients with treated IAs (by coil embolization or surgical clipping) will be excluded.
• Patients presenting with ruptured intracranial IAs will also be excluded from the study, to avoid interfering with timely treatment of ruptured IAs.
• Children
• pregnant women
• persons with history of allergy or hypersensitivity to iron or dextran or iron-polysaccharide preparations
• patients requiring monitored anesthesia or intravenous (IV) sedation for MR imaging
• patients with contraindication to MRI
• patients with renal insufficiency, hepatic insufficiency or iron overload, 9. patients receiving combination antiretroviral therapy.

Where it is running

• University of Iowa hospitals and Clinics — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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