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LIMITS: Levels of Inflammatory Markers in the Treatment of Stroke-An SPS3 Ancillary Study

Sponsor
Columbia University (Other)
Overall Status
Completed
CT.gov ID
NCT00579306
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
1,244
Enrollment
45
Locations
85
Actual Duration (Months)
27.6
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goals of this trial are to determine the prognostic significance of an elevated level of inflammatory blood markers in people who have experienced small subcortical strokes and who are enrolled in the Secondary Prevention of Small Subcortical Strokes (SPS3) trial.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Inflammation is increasingly recognized as playing a central role in atherosclerosis and coronary artery disease. And, peripheral blood markers of inflammation have been associated with incident and recurrent cardiac events. The relationship of these risk markers-which have the potential to be modified-to prognosis after ischemic stroke is less clear.

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1244 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Levels of Inflammatory Markers in the Treatment of Stroke
    Actual Study Start Date :
    Jun 1, 2005
    Actual Primary Completion Date :
    Apr 1, 2012
    Actual Study Completion Date :
    Jul 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    SPS3 patient cohort

    All SPS3 patients who participate in Baseline and 1-Year F/U blood draw

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of participants with recurrent stroke [Up to 5 years]

      Participants with recurrence of any stroke during follow-up, including ischemic (an acute localized ischemic lesion in the brain not attributable to central nervous system infection, tumor, demyelinating, or degenerative neurologic diseases due to an occlusive vascular disorder) and hemorrhagic (acute extravasation of blood into the parenchyma of the central nervous system or subarachnoid space).

    Secondary Outcome Measures

    1. Percentage of participants developing major cognitive decline [Up to 5 years]

      Documentation of a major cognitive decline during follow-up. This is a clinical decline in cognitive function manifested by functional deterioration/behavioral changes that are not associated with a clinical stroke event. Criteria: Both A and B must be met: A) A drop in the Cognitive Abilities Screening Instrument (CASI) score of > 10 points since study entry and sustained on repeat testing in approximately one month B) Associated behavioral changes and/or function

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patient must be randomized within 6 months of qualifying small subcortical stroke (S3) or subcortical TIA

    • 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:

    • Disabling stroke (Ranking Scale >= 4)

    • 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of South Alabama Mobile Alabama United States 36617
    2 Mayo Clinic Scottsdale Scottsdale Arizona United States 85259
    3 University of Arizona Collage of Medicine Tucson Arizona United States 85724
    4 University of California, San Diego Medical Center La Jolla California United States 92093-0979
    5 Sutter Neuroscience Institute Sacramento California United States 95816
    6 Melbourne Internal Medicine Associates Melbourne Florida United States 32901
    7 University of Miami Miami Florida United States 33136
    8 Mercy Medical Center Des Moines Iowa United States 50314
    9 University of Kentucky Lexington Kentucky United States 40536
    10 Boston University Medical Center Boston Massachusetts United States 02118
    11 Wayne State University Detroit Michigan United States 48201
    12 Henry Ford Health System Detroit Michigan United States 48202
    13 Hennepin County Medical Center Minneapolis Minnesota United States 55404
    14 Mayo Clinic Rochester Rochester Minnesota United States 55905
    15 St. Louis University Saint Louis Missouri United States 63104
    16 St. John's Mercy Medical Center Saint Louis Missouri United States 63141
    17 Cooper University Hospital, Camden New Jersey United States 08103
    18 Columbia University Medical Center New York New York United States 10032
    19 Rochester General Hospital Rochester New York United States 14621
    20 University of Rochester Medical Center Rochester New York United States 14642
    21 Helen Hayes Hospital West Haverstraw New York United States 10993
    22 Wake Forest University Medical Center Winston-Salem North Carolina United States 27157-1078
    23 University Hospitals of Cleveland, Case Western Reserve University,Case Western Neurological Unit, 11100 Euclid Avenue, Lakeside 5508 Cleveland Ohio United States 44106
    24 Metro Health Medical Center Cleveland Ohio United States 44109
    25 Oregon Health and Science University Portland Oregon United States 97239
    26 University of Texas South Western Medical Center Dallas Texas United States 75390-8897
    27 The Methodist Hospital Houston Texas United States 77030
    28 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    29 Marshfield Clinic Research Foundation Marshfield Wisconsin United States 54449
    30 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    31 Dalhousie University Center for Clinical Research Halifax Nova Scotia Canada B3H 4V7
    32 Hospital Charles LeMoyne Centre de recherché Greenfield Park Quebec Canada J4V 2H1
    33 McGill University Health Center Montreal Quebec Canada H3G 1A4
    34 Pontificia Universidad Catolica de Chile Santiago Chile
    35 Hospital Naval Almirante Nef Viña del Mar Chile 2530116
    36 Hospital-Clinica Kennedy Guayaquil Ecuador
    37 Universidad Autonoma de Guadalajara Guadalajara JAL Mexico 44280
    38 Instituto Nacional de Neurología y Neurocirugía Mexico Mexico City Mexico 14269
    39 Hospital Nacional Alberto Sabogal Lima Peru 41
    40 Hospital Clinico Universitario de Santiago de Compostela Barcelona Spain 08907
    41 Hospital del Mar Barcelona Spain 08907
    42 Hospital del Sagrat Cor Barcelona Spain 08907
    43 Hospital Dr. Josep Trueta Barcelona Spain 08907
    44 Hospital Germans Trias i Pujol, Barcelona Spain 08907
    45 Hospital Universitario de Bellvitge, Spain Barcelona Spain 08907

    Sponsors and Collaborators

    • Columbia University
    • National Institute of Neurological Disorders and Stroke (NINDS)

    Investigators

    • Principal Investigator: Mitchell S. Elkind, MD, MS, FAAN, Columbia University
    • Principal Investigator: Oscar Benavente, MD, UTHSC San Antonio (SPS3 Principal Investigator)
    • Principal Investigator: Robert Hart, MD, UTHSC San Antonio (SPS3 Principal Investigator)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitchell S Elkind, Associate Professor of Neurology and Epidemiology (in the Sergievsy Center), Columbia University
    ClinicalTrials.gov Identifier:
    NCT00579306
    Other Study ID Numbers:
    • AAAB1202
    • R01NS050724
    First Posted:
    Dec 24, 2007
    Last Update Posted:
    Jul 24, 2017
    Last Verified:
    Jul 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mitchell S Elkind, Associate Professor of Neurology and Epidemiology (in the Sergievsy Center), Columbia University
    hypertension
    stroke
    cerebrovascular accident
    Additional relevant MeSH terms:
    Stroke
    Hypertension

    Study Results

    No Results Posted as of Jul 24, 2017