Trial record 2 of 145 for:
Cerebral Aneurysm
Aspirin Attenuates Inflammation in Human Cerebral Aneurysms
This study is currently recruiting participants.
Verified October 2012 by University of Iowa
Sponsor:
University of Iowa
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
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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:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
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 May 19, 2013