Trial record 2 of 190 for:    Cerebral Aneurysms

Aspirin Attenuates Inflammation in Human Cerebral Aneurysms

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University of Iowa
Sponsor:
Information provided by (Responsible Party):
David Hasan, University of Iowa
ClinicalTrials.gov Identifier:
NCT01710072
First received: October 15, 2012
Last updated: October 16, 2012
Last verified: October 2012
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    at the end of the 3 months, the MRI signal intensity are measured and compared to the baseline


Estimated Enrollment: 15
Study Start Date: August 2011
Estimated Study Completion Date: August 2014
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01710072

Contacts
Contact: David Hasan, MD 319-400-9455 david-hasan@uiowa.edu

Locations
United States, Iowa
University of Iowa hospitals and Clinics Recruiting
Iowa CIty, Iowa, United States, 52242
Principal Investigator: David Hasan, MD         
Sponsors and Collaborators
University of Iowa
  More Information

No publications provided by University of Iowa

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Hasan, Assistant Professor and Section Chief, University of Iowa
ClinicalTrials.gov Identifier: NCT01710072     History of Changes
Other Study ID Numbers: 201108750
Study First Received: October 15, 2012
Last Updated: October 16, 2012
Health Authority: United States: Safety Monitoring Gorup in the Neurosurgery Department

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

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Brain Diseases
Inflammation
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Arterial Diseases
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014