Levels of Inflammatory Markers in the Treatment of Stroke—An SPS3 Ancillary Study (LIMITS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mitchell S Elkind, Columbia University
ClinicalTrials.gov Identifier:
NCT00579306
First received: December 20, 2007
Last updated: December 6, 2012
Last verified: December 2012
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Levels of Inflammatory Markers in the Treatment of Stroke

Resource links provided by NLM:


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

blood serum


Estimated Enrollment: 1440
Study Start Date: June 2005
Estimated Study Completion Date: August 2013
Primary Completion Date: April 2012 (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; 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 45 Study Locations
Sponsors and Collaborators
Columbia University
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)
  More Information

Additional Information:
No publications provided

Responsible Party: Mitchell S Elkind, Associate Professor of Neurology and Epidemiology (in the Sergievsy Center), Columbia University
ClinicalTrials.gov Identifier: NCT00579306     History of Changes
Other Study ID Numbers: AAAB1202, R01NS050724
Study First Received: December 20, 2007
Last Updated: December 6, 2012
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 Pública 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

Additional relevant MeSH terms:
Hypertension
Stroke
Cerebral Infarction
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 28, 2014