HypertensionLIMITSNCT00579306
Levels of Inflammatory Markers in the Treatment of Stroke-An SPS3 Ancillary Study
An observational study of Hypertension and Stroke, run by Columbia University at 45 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Hypertension, Stroke
- How many people
- 1,244 participants
- Where
- 45 sitesin 7 countries
- Study dates
- Jun 2005to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a symptomatic small vessel stroke within prior 6 month and enrolled in SPS3
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
45 sites in 7 countries.
45 sites in 7 countries
United States30 sites
Boston University Medical Center
Boston, Massachusetts, 02118
Cooper University Hospital,
Camden, New Jersey, 08103
University Hospitals of Cleveland, Case Western Reserve University,Case Western Neurological Unit, 11100 Euclid Avenue, Lakeside 5508
Cleveland, Ohio, 44106
Metro Health Medical Center
Cleveland, Ohio, 44109
University of Texas South Western Medical Center
Dallas, Texas, 75390-8897
Mercy Medical Center
Des Moines, Iowa, 50314
Wayne State University
Detroit, Michigan, 48201
Henry Ford Health System
Detroit, Michigan, 48202
The Methodist Hospital
Houston, Texas, 77030
University of California, San Diego Medical Center
La Jolla, California, 92093-0979
University of Kentucky
Lexington, Kentucky, 40536
Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
Melbourne Internal Medicine Associates
Melbourne, Florida, 32901
University of Miami
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Hennepin County Medical Center
Minneapolis, Minnesota, 55404
University of South Alabama
Mobile, Alabama, 36617
Columbia University Medical Center
New York, New York, 10032
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Rochester General Hospital
Rochester, New York, 14621
University of Rochester Medical Center
Rochester, New York, 14642
Sutter Neuroscience Institute
Sacramento, California, 95816
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
St. Louis University
St Louis, Missouri, 63104
St. John's Mercy Medical Center
St Louis, Missouri, 63141
University of Arizona Collage of Medicine
Tucson, Arizona, 85724
Helen Hayes Hospital
West Haverstraw, New York, 10993
Wake Forest University Medical Center
Winston-Salem, North Carolina, 27157-1078
Spain6 sites
Hospital Clinico Universitario de Santiago de Compostela
Barcelona, 08907
Hospital del Mar
Barcelona, 08907
Hospital del Sagrat Cor
Barcelona, 08907
Hospital Dr. Josep Trueta
Barcelona, 08907
Hospital Germans Trias i Pujol,
Barcelona, 08907
Hospital Universitario de Bellvitge, Spain
Barcelona, 08907
Canada3 sites
Hospital Charles LeMoyne Centre de recherché
Greenfield Park, Quebec, J4V 2H1
Dalhousie University Center for Clinical Research
Halifax, Nova Scotia, B3H 4V7
McGill University Health Center
Montreal, Quebec, H3G 1A4
Chile2 sites
Pontificia Universidad Catolica de Chile
Santiago
Hospital Naval Almirante Nef
Viña del Mar, 2530116
Mexico2 sites
Universidad Autonoma de Guadalajara
Guadalajara, Jalisco, 44280
Instituto Nacional de Neurología y Neurocirugía
Mexico City, Mexico City, 14269
About this study
Official title: Levels of Inflammatory Markers in the Treatment of Stroke
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.
Read the 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.
- Conditions
- Hypertension, Stroke
- Keywords
- hypertension, stroke, cerebrovascular accident
- Medical subject headings
- Hypertension, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SPS3 patient cohort | All SPS3 patients who participate in Baseline and 1-Year F/U blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with recurrent stroke
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).
Measured: Up to 5 years
Secondary outcomes (1)
Percentage of participants developing major cognitive decline
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 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
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startJun 2005
- Primary completionApr 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitchell S Elkind, Columbia University
- Investigators
- Mitchell S. Elkind, MD, MS, FAAN, Principal investigator, Columbia UniversityOscar Benavente, MD, Principal investigator, UTHSC San Antonio (SPS3 Principal Investigator)Robert Hart, MD, Principal investigator, UTHSC San Antonio (SPS3 Principal Investigator)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579306
- Sponsor's protocol ID
- AAAB1202
- Other IDs
- R01NS050724
- Acronym
- LIMITS
- Status last verified
- Jul 2017
- First submitted
- 20 Dec 2007
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levels of Inflammatory Markers in the Treatment of Stroke
- ClinicalTrials.gov ID
- NCT00579306
- Acronym / sponsor ID
- LIMITS / AAAB1202
- Conditions
- Hypertension, Stroke
- Keywords
- hypertension, stroke, cerebrovascular accident
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,244 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jun 2005 (actual)
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 24 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPS3 patient cohort | – | –All SPS3 patients who participate in Baseline and 1-Year F/U blood draw |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a symptomatic small vessel stroke within prior 6 month and enrolled in SPS3
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of participants with recurrent stroke
Time frame: 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).
1 secondary outcome
Percentage of participants developing major cognitive decline
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell S. Elkind, MD, MS, FAAN principal investigator
Columbia University
Oscar Benavente, MD principal investigator
UTHSC San Antonio (SPS3 Principal Investigator)
Robert Hart, MD principal investigator
UTHSC San Antonio (SPS3 Principal Investigator)
45 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Stroke, run by Columbia University at 45 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Spain, Canada, Chile, Mexico and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with recurrent stroke (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.