Levels of Inflammatory Markers in the Treatment of Stroke-An SPS3 Ancillary Study (LIMITS)
Levels of Inflammatory Markers in the Treatment of Stroke
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 4V7
- Dalhousie University Center for Clinical Research
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Quebec
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Greenfield Park, Quebec, Canadá, J4V 2H1
- Hospital Charles LeMoyne Centre de recherché
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Montreal, Quebec, Canadá, H3G 1A4
- McGill University Health Center
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Santiago, Chile
- Pontificia Universidad Catolica de Chile
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Viña del Mar, Chile, 2530116
- Hospital Naval Almirante Nef
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Guayaquil, Ecuador
- Hospital-Clinica Kennedy
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Barcelona, España, 08907
- Hospital Clinico Universitario De Santiago De Compostela
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Barcelona, España, 08907
- Hospital Del Mar
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Barcelona, España, 08907
- Hospital del Sagrat Cor
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Barcelona, España, 08907
- Hospital Dr. Josep Trueta
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Barcelona, España, 08907
- Hospital Germans Trias i Pujol,
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Barcelona, España, 08907
- Hospital Universitario de Bellvitge, Spain
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Alabama
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Mobile, Alabama, Estados Unidos, 36617
- University of South Alabama
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259
- Mayo Clinic Scottsdale
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Tucson, Arizona, Estados Unidos, 85724
- University of Arizona Collage of Medicine
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California
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La Jolla, California, Estados Unidos, 92093-0979
- University of California, San Diego Medical Center
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Sacramento, California, Estados Unidos, 95816
- Sutter Neuroscience Institute
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Florida
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Melbourne, Florida, Estados Unidos, 32901
- Melbourne Internal Medicine Associates
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Miami, Florida, Estados Unidos, 33136
- University of Miami
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Iowa
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Des Moines, Iowa, Estados Unidos, 50314
- Mercy Medical Center
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536
- University of Kentucky
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Boston University Medical Center
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Health System
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Detroit, Michigan, Estados Unidos, 48201
- Wayne State University
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55404
- Hennepin County Medical Center
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Rochester
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63104
- St. Louis University
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Saint Louis, Missouri, Estados Unidos, 63141
- St. John's Mercy Medical Center
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New Jersey
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Camden, New Jersey, Estados Unidos, 08103
- Cooper University Hospital,
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New York
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New York, New York, Estados Unidos, 10032
- Columbia University Medical Center
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Rochester, New York, Estados Unidos, 14642
- University of Rochester Medical Center
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Rochester, New York, Estados Unidos, 14621
- Rochester General Hospital
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West Haverstraw, New York, Estados Unidos, 10993
- Helen Hayes Hospital
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27157-1078
- Wake Forest University Medical Center
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- University Hospitals of Cleveland, Case Western Reserve University,Case Western Neurological Unit, 11100 Euclid Avenue, Lakeside 5508
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Cleveland, Ohio, Estados Unidos, 44109
- Metro Health Medical Center
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health and Science University
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Texas
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Dallas, Texas, Estados Unidos, 75390-8897
- University of Texas South Western Medical Center
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Houston, Texas, Estados Unidos, 77030
- The Methodist Hospital
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San Antonio, Texas, Estados Unidos, 78229
- University of Texas Health Science Center at San Antonio
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Wisconsin
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Marshfield, Wisconsin, Estados Unidos, 54449
- Marshfield Clinic Research Foundation
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Milwaukee, Wisconsin, Estados Unidos, 53226
- Medical College of Wisconsin
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JAL
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Guadalajara, JAL, México, 44280
- Universidad Autonoma de Guadalajara
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Mexico City
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Mexico, Mexico City, México, 14269
- Instituto Nacional de Neurologia y Neurocirugia
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Lima, Perú, 41
- Hospital Nacional Alberto Sabogal
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
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SPS3 patient cohort
All SPS3 patients who participate in Baseline and 1-Year F/U blood draw
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of participants with recurrent stroke
Periodo de tiempo: Up to 5 years
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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).
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Up to 5 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of participants developing major cognitive decline
Periodo de tiempo: Up to 5 years
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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 |
Up to 5 years
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mitchell S. Elkind, MD, MS, FAAN, Columbia University
- Investigador principal: Oscar Benavente, MD, UTHSC San Antonio (SPS3 Principal Investigator)
- Investigador principal: Robert Hart, MD, UTHSC San Antonio (SPS3 Principal Investigator)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AAAB1202
- R01NS050724 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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