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Aspirin Attenuates Inflammation in Human Cerebral Aneurysms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01710072
Recruitment Status : Completed
First Posted : October 18, 2012
Last Update Posted : May 29, 2015
Information provided by (Responsible Party):
David Hasan, University of Iowa

Brief Summary:

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 or disease Intervention/treatment 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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Aspirin as a Promising Agent to Attenuate Inflammation in the Wall of Human Cerebral Aneurysms
Study Start Date : August 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms
Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: aspirin
aspirin 81 mg po every day
Drug: aspirin
No Intervention: no aspirin

Primary Outcome Measures :
  1. 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 :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01710072

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David Hasan, Assistant Professor and Section Chief, University of Iowa Identifier: NCT01710072     History of Changes
Other Study ID Numbers: 201108750
First Posted: October 18, 2012    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

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

Additional relevant MeSH terms:
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Intracranial Aneurysm
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
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