Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-03-04 @ 8:10 PM
Study NCT ID:
NCT00579306
Status:
COMPLETED
Last Update Posted:
2017-07-24
First Post:
2007-12-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Levels of Inflammatory Markers in the Treatment of Stroke-An SPS3 Ancillary Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood serum (ancillary study)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1244}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-20', 'studyFirstSubmitDate': '2007-12-20', 'studyFirstSubmitQcDate': '2007-12-20', 'lastUpdatePostDateStruct': {'date': '2017-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with recurrent stroke', 'timeFrame': 'Up to 5 years', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants developing major cognitive decline', 'timeFrame': 'Up to 5 years', 'description': '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.\n\nCriteria: Both A and B must be met:\n\nA) 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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypertension', 'stroke', 'cerebrovascular accident'], 'conditions': ['Hypertension', 'Stroke']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a symptomatic small vessel stroke within prior 6 month and enrolled in SPS3', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient must be randomized within 6 months of qualifying small subcortical stroke (S3) or subcortical TIA\n* 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\n* Absence of cortical dysfunction (aphasia, apraxia, agnosia)\n* No ipsilateral cervical carotid stenosis (\\>= 50%) if S3 is hemispheric\n* No major-risk cardioembolic sources requiring anti-coagulation\n* 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.\n\nExclusion Criteria:\n\n* Disabling stroke (Ranking Scale \\>= 4)\n* Prior hemorrhagic stroke\n* Age \\<30 years\n* High risk of bleeding (recurrent GI or GU bleeding, active peptic ulcer disease, etc)\n* Need for long-term use of anticoagulants or other antiplatelet agents.\n* Prior cortical or retinal stroke / TIA\n* Prior ipsilateral carotid endarterectomy if hemispheric S3\n* Impaired renal function: GFR\\<40 cc/min\n* Intolerance/contraindication to aspirin or clopidogrel\n* Adjusted Folstein MMSE \\<24\n* Medical contraindication to MRI\n* Pregnancy or child-bearing potential without contraception\n* Other specific causes of stroke (e.g. dissection, vasculitis, drug abuse)'}, 'identificationModule': {'nctId': 'NCT00579306', 'acronym': 'LIMITS', 'briefTitle': 'Levels of Inflammatory Markers in the Treatment of Stroke-An SPS3 Ancillary Study', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Levels of Inflammatory Markers in the Treatment of Stroke', 'orgStudyIdInfo': {'id': 'AAAB1202'}, 'secondaryIdInfos': [{'id': 'R01NS050724', 'link': 'https://reporter.nih.gov/quickSearch/R01NS050724', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'SPS3 patient cohort', 'description': 'All SPS3 patients who participate in Baseline and 1-Year F/U blood draw'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36617', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona Collage of Medicine', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92093-0979', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Neuroscience Institute', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '32901', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'Melbourne Internal Medicine Associates', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '50314', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Mercy Medical Center', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St. John's Mercy Medical Center", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper University Hospital,', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14621', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester General Hospital', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '10993', 'city': 'West Haverstraw', 'state': 'New York', 'country': 'United States', 'facility': 'Helen Hayes Hospital', 'geoPoint': {'lat': 41.20954, 'lon': -73.98542}}, {'zip': '27157-1078', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland, Case Western Reserve University,Case Western Neurological Unit, 11100 Euclid Avenue, Lakeside 5508', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Metro Health Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '75390-8897', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas South Western Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Clinic Research Foundation', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'B3H 4V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Dalhousie University Center for Clinical Research', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'J4V 2H1', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hospital Charles LeMoyne Centre de recherché', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Center', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Pontificia Universidad Catolica de Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '2530116', 'city': 'Viña del Mar', 'country': 'Chile', 'facility': 'Hospital Naval Almirante Nef', 'geoPoint': {'lat': -33.02457, 'lon': -71.55183}}, {'city': 'Guayaquil', 'country': 'Ecuador', 'facility': 'Hospital-Clinica Kennedy', 'geoPoint': {'lat': -2.19616, 'lon': -79.88621}}, {'zip': '44280', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'Universidad Autonoma de Guadalajara', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '14269', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Neurología y Neurocirugía', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '41', 'city': 'Lima', 'country': 'Peru', 'facility': 'Hospital Nacional Alberto Sabogal', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '08907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Santiago de Compostela', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Sagrat Cor', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Dr. Josep Trueta', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Germans Trias i Pujol,', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitario de Bellvitge, Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Mitchell S. Elkind, MD, MS, FAAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Oscar Benavente, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTHSC San Antonio (SPS3 Principal Investigator)'}, {'name': 'Robert Hart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTHSC San Antonio (SPS3 Principal Investigator)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Neurology and Epidemiology (in the Sergievsy Center)', 'investigatorFullName': 'Mitchell S Elkind', 'investigatorAffiliation': 'Columbia University'}}}}