NCT01710072

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

3 years

First QC Date

October 15, 2012

Last Update Submit

May 28, 2015

Conditions

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

Keywords

aneurysm, inflammation, MRI

Outcome Measures

Primary Outcomes (1)

  • measurement of inflammatory biomarkers

    At the end of treatment, Inflammatory biomarkers are used to assess the efficacy of treatment (aspirin)

    3 months

Secondary Outcomes (1)

  • change in the signal intensity of MRI

    3 months

Study Arms (2)

aspirin

EXPERIMENTAL

aspirin 81 mg po every day

Drug: aspirin

no aspirin

NO INTERVENTION

Interventions

aspirinDRUG
aspirin

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

  • Hasan DM, Chalouhi N, Jabbour P, Dumont AS, Kung DK, Magnotta VA, Young WL, Hashimoto T, Richard Winn H, Heistad D. Evidence that acetylsalicylic acid attenuates inflammation in the walls of human cerebral aneurysms: preliminary results. J Am Heart Assoc. 2013 Feb 22;2(1):e000019. doi: 10.1161/JAHA.112.000019.

    PMID: 23525414DERIVED

MeSH Terms

Conditions

AneurysmInflammation

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor and Section Chief

Study Record Dates

First Submitted

October 15, 2012

First Posted

October 18, 2012

Study Start

August 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

US(1)