Levels of Inflammatory Markers in the Treatment of Stroke-An SPS3 Ancillary Study
NCT ID: NCT00579306
Last Updated: 2017-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1244 participants
OBSERVATIONAL
2005-06-30
2012-07-31
Brief Summary
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Detailed Description
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The Levels of Inflammatory Markers in the Treatment of Stroke (LIMITS) study will address questions about the role of inflammatory markers in secondary stroke prevention in a cost-effective manner using the well-established framework of the Secondary Prevention of Small Subcortical Strokes (SPS3) trial. The SPS3 trial is an ongoing Phase 3, multicenter secondary stroke prevention trial that focuses on preventing stroke recurrence in people with small vessel ischemic stroke, or lacunes.
The overall purpose of the LIMITS study is to determine if serum levels of inflammatory markers-such as hsCRP, serum amyloid A (SAA), CD40 ligand (CD40L), and monocyte chemoattractant protein-1 (MCP-1)-predict recurrent stroke and other vascular events among people with a history of small artery ischemic stroke. The project will also determine if these markers predict which people will respond best to dual antiplatelet therapy with clopidogrel and aspirin.
The specific aims of LIMITS are to determine if hsCRP, SAA, CD40L, and MCP-1 levels are independent risk factors for recurrent ischemic stroke, and for recurrent ischemic stroke, myocardial infarction, and death in participants in the SPS3 trial after adjusting for demographic and traditional stroke risk factors, and other treatments, using a prospective cohort of people with small subcortical strokes from the SPS3 trial. LIMITS also aims to compare the efficacy of dual versus single antiplatelet therapy among participant groups with and without elevated baseline inflammatory marker levels for the outcome of a.) recurrent stroke, and b.) recurrent ischemic stroke, myocardial infarction, or death.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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SPS3 patient cohort
All SPS3 patients who participate in Baseline and 1-Year F/U blood draw
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* One of the following lacunar syndromes: PMH; pure sensory stroke; sensorimotor stroke; ataxic hemiparesis; dysarthria; hemiballism; PMH with facial sparing, horizontal gaze palsy, contralateral III palsy, contralateral VI palsy; Ataxia with contralateral III palsy; pure dysarthria
* Absence of cortical dysfunction (aphasia, apraxia, agnosia)
* No ipsilateral cervical carotid stenosis (\>= 50%) if S3 is hemispheric
* No major-risk cardioembolic sources requiring anti-coagulation
* MRI evidence of S3 that is \>=2.0 cm in diameter if DWI/bright lesion on FLAIR/T2 or \<=1.5cm hypointense lesion on FLAIR/T1, corresponding to the qualifying event (required for all brainstem events) OR multiple S3 in cerebral hemispheres of \<=1.5cm hypointense lesions on FLAIR/T1 AND absence of cortical stroke and large subcortical stroke.
Exclusion Criteria
* Prior hemorrhagic stroke
* Age \<30 years
* High risk of bleeding (recurrent GI or GU bleeding, active peptic ulcer disease, etc)
* Need for long-term use of anticoagulants or other antiplatelet agents.
* Prior cortical or retinal stroke / TIA
* Prior ipsilateral carotid endarterectomy if hemispheric S3
* Impaired renal function: GFR\<40 cc/min
* Intolerance/contraindication to aspirin or clopidogrel
* Adjusted Folstein MMSE \<24
* Medical contraindication to MRI
* Pregnancy or child-bearing potential without contraception
* Other specific causes of stroke (e.g. dissection, vasculitis, drug abuse)
30 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Columbia University
OTHER
Responsible Party
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Mitchell S Elkind
Associate Professor of Neurology and Epidemiology (in the Sergievsy Center)
Principal Investigators
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Mitchell S. Elkind, MD, MS, FAAN
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Oscar Benavente, MD
Role: PRINCIPAL_INVESTIGATOR
UTHSC San Antonio (SPS3 Principal Investigator)
Robert Hart, MD
Role: PRINCIPAL_INVESTIGATOR
UTHSC San Antonio (SPS3 Principal Investigator)
Locations
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University of South Alabama
Mobile, Alabama, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
University of Arizona Collage of Medicine
Tucson, Arizona, United States
University of California, San Diego Medical Center
La Jolla, California, United States
Sutter Neuroscience Institute
Sacramento, California, United States
Melbourne Internal Medicine Associates
Melbourne, Florida, United States
University of Miami
Miami, Florida, United States
Mercy Medical Center
Des Moines, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Boston University Medical Center
Boston, Massachusetts, United States
Wayne State University
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
St. Louis University
St Louis, Missouri, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
Cooper University Hospital,
Camden, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Rochester General Hospital
Rochester, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Helen Hayes Hospital
West Haverstraw, New York, United States
Wake Forest University Medical Center
Winston-Salem, North Carolina, United States
University Hospitals of Cleveland, Case Western Reserve University,Case Western Neurological Unit, 11100 Euclid Avenue, Lakeside 5508
Cleveland, Ohio, United States
Metro Health Medical Center
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Texas South Western Medical Center
Dallas, Texas, United States
The Methodist Hospital
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Dalhousie University Center for Clinical Research
Halifax, Nova Scotia, Canada
Hospital Charles LeMoyne Centre de recherché
Greenfield Park, Quebec, Canada
McGill University Health Center
Montreal, Quebec, Canada
Pontificia Universidad Catolica de Chile
Santiago, , Chile
Hospital Naval Almirante Nef
Viña del Mar, , Chile
Hospital-Clinica Kennedy
Guayaquil, , Ecuador
Universidad Autonoma de Guadalajara
Guadalajara, Jalisco, Mexico
Instituto Nacional de Neurología y Neurocirugía
Mexico City, Mexico City, Mexico
Hospital Nacional Alberto Sabogal
Lima, , Peru
Hospital Clinico Universitario de Santiago de Compostela
Barcelona, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital del Sagrat Cor
Barcelona, , Spain
Hospital Dr. Josep Trueta
Barcelona, , Spain
Hospital Germans Trias i Pujol,
Barcelona, , Spain
Hospital Universitario de Bellvitge, Spain
Barcelona, , Spain
Countries
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Other Identifiers
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AAAB1202
Identifier Type: -
Identifier Source: org_study_id
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