Levels of Inflammatory Markers in the Treatment of Stroke—An SPS3 Ancillary Study - Full Text View

Sponsors and Collaborators:	Columbia University National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00579306

Purpose

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
Hypertension Stroke

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Levels of Inflammatory Markers in the Treatment of Stroke

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

Ischemic stroke, myocardial infarction, death. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Major Cognitive Decline. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

blood serum

Estimated Enrollment:	1440
Study Start Date:	June 2005
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

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

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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients with a symptomatic small vessel stroke within prior 6 month and enrolled in SPS3

Criteria

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; dysathria; hemiballism; PMH with facial sparing, horizontal gaze palsy, contralateral III palsy, contralateral VI palsy; Ataxia with contraleteral 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 hemisoheric 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579306

Contacts

Contact: Jorge M Luna

212-305-5507

jluna@neuro.columbia.edu

Show 45 Study Locations

Sponsors and Collaborators

Columbia University

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator:	Mitchell S.V. 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)

More Information

Additional Information:

website containing associated parent SPS3 trial information This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Columbia University ( Mitchell S.V. Elkind, M.D., M.S., F.A.A.N., Principal Investigator/Associate Professor of Neurology )
Study ID Numbers:	R01NS050724
Study First Received:	December 20, 2007
Last Updated:	May 27, 2009
ClinicalTrials.gov Identifier:	NCT00579306 History of Changes
Health Authority:	United States: Federal Government; United States: Food and Drug Administration; Mexico: Comisión Federal para la Protección Contra Riesgos Sanitarios; Spain: Agencia Española de Medicamentos y Productos Sanitarios; Chile: Instituto de Salud Publica de Chile; Peru: Ministerio de Salud del Peru; Canada: Health Canada; Ecuador: Ministerio de Salud Publica

Keywords provided by Columbia University:

hypertension
stroke
cerebrovascular accident

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases
Ischemia

Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders
Hypertension

Additional relevant MeSH terms:

Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases

Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders
Hypertension

ClinicalTrials.gov processed this record on September 10, 2009