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Aspirin Attenuates Inflammation in Human Cerebral Aneurysms

This study has been completed.
Information provided by (Responsible Party):
David Hasan, University of Iowa Identifier:
First received: October 15, 2012
Last updated: May 28, 2015
Last verified: May 2015

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.

Condition Intervention Phase
The Focus of the Study is to Monitor MRI Signal Changes and Inflammatory Biomarkers With Use of Aspirin in Patients With Unruptured Cerebral Aneurysm
Drug: aspirin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Aspirin as a Promising Agent to Attenuate Inflammation in the Wall of Human Cerebral Aneurysms

Resource links provided by NLM:

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • measurement of inflammatory biomarkers [ Time Frame: 3 months ]
    At the end of treatment, Inflammatory biomarkers are used to assess the efficacy of treatment (aspirin)

Secondary Outcome Measures:
  • change in the signal intensity of MRI [ Time Frame: 3 months ]
    at the end of the 3 months, the MRI signal intensity are measured and compared to the baseline

Enrollment: 11
Study Start Date: August 2011
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aspirin
aspirin 81 mg po every day
Drug: aspirin
No Intervention: no aspirin

  Show Detailed Description


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with treated IAs (by coil embolization or surgical clipping) will be excluded.
  2. Patients presenting with ruptured intracranial IAs will also be excluded from the study, to avoid interfering with timely treatment of ruptured IAs.
  3. Children
  4. pregnant women
  5. persons with history of allergy or hypersensitivity to iron or dextran or iron-polysaccharide preparations
  6. patients requiring monitored anesthesia or intravenous (IV) sedation for MR imaging
  7. patients with contraindication to MRI
  8. patients with renal insufficiency, hepatic insufficiency or iron overload, 9. patients receiving combination antiretroviral therapy.
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Please refer to this study by its identifier: NCT01710072

United States, Iowa
University of Iowa hospitals and Clinics
Iowa CIty, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: David Hasan, Assistant Professor and Section Chief, University of Iowa Identifier: NCT01710072     History of Changes
Other Study ID Numbers: 201108750
Study First Received: October 15, 2012
Last Updated: May 28, 2015

Keywords provided by University of Iowa:
aneurysm, inflammation, MRI

Additional relevant MeSH terms:
Intracranial Aneurysm
Brain Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics processed this record on April 24, 2017