Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-20 @ 1:14 AM
Study NCT ID:
NCT02171858
Status:
UNKNOWN
Last Update Posted:
2014-06-24
First Post:
2014-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multivariate Analysis of Serum High Sensitivity C-Reactive Protein in Patients With Acute Phase Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'lastUpdateSubmitDate': '2014-06-21', 'studyFirstSubmitDate': '2014-06-04', 'studyFirstSubmitQcDate': '2014-06-21', 'lastUpdatePostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Stroke extension', 'timeFrame': 'within the first 4 hours since admission to emergency room', 'description': 'brain image will be taken as soon as possible when patient suspected with stroke arrives to emergency room and after clinical evaluation'}, {'measure': 'Origin of stroke', 'timeFrame': 'origin will be diagnosed during the hospital stay expecting no more than 1 week', 'description': 'origin of stroke will be investigated within hospital stay'}, {'measure': 'Hospital stay', 'timeFrame': 'hospital stay is expected for no more than 1 week unless intensive care unit is needed', 'description': 'from arrival of patient to emergency room until discharge'}], 'primaryOutcomes': [{'measure': 'Measure of serum High sensitivity C-Reactive Protein level', 'timeFrame': 'within the first 8 hours since admission to hospital', 'description': 'Serum levels of serum High sensitivity C-Reactive Protein will be measured in patients with suspicion of stroke at the emergency room within the first 8 hours of arrival at our hospital'}], 'secondaryOutcomes': [{'measure': 'National Institutes of Health Stroke Scale', 'timeFrame': 'within the first 4 hours since admission to emergency room', 'description': 'clinical impact of stroke will be determined by neurology and neurosurgery department at admission to emergency room of our hospital'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stroke', 'National Institutes of Health Stroke Scale', 'Serum high sensitivity C-Reactive Protein'], 'conditions': ['Stroke', 'National Institutes of Health Stroke Scale', 'Serum High Sensitivity C-Reactive Protein']}, 'descriptionModule': {'briefSummary': 'Stroke is one of main causes of death and impairment worldwide. Objective of this study is to analyze serum High Sensitivity C-Reactive Protein in acute phase stroke in patients attended at Petróleos Mexicanos Hospital Central Sur de Alta Especialidad and to correlate with stroke extension and clinical features.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affiliated to Petróleos Mexicanos medical system of any gender between 18 and 80 years old suspected of acute phase stroke who arrive to emergency room at our hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suspected of acute phase stroke who arrive to emergency room at our hospital\n* Patients affiliated to Petróleos Mexicanos medical system\n* Patients of any gender\n* Patients between 18 and 80 years old\n\nExclusion Criteria:\n\n* Stroke provoked by angiographic procedure\n* Pregnancy\n* Patient under chemotherapy or radiotherapy\n* Recently surgery or trauma among last 30 days\n* Heparin usage\n* Stroke and/ or thrombolysis history\n* Active infection\n* Liver disease'}, 'identificationModule': {'nctId': 'NCT02171858', 'acronym': 'MAASP', 'briefTitle': 'Multivariate Analysis of Serum High Sensitivity C-Reactive Protein in Patients With Acute Phase Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Central Sur de Alta Especialidad'}, 'officialTitle': 'Multivariate Analysis of Serum High Sensitivity C-Reactive Protein in Patients With Acute Phase Stroke', 'orgStudyIdInfo': {'id': 'CRP-S1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'stroke', 'description': 'Patients admitted to hospital who are diagnosed with stroke will be treated as usually a our center by observation, venous or arterial thrombolysis depending on extension, condition, thrombolysis feasibility.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14140', 'city': 'Mexico City', 'state': 'Tlalpan', 'country': 'Mexico', 'facility': 'Hospital Central Sur Alta Especialidad', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Central Sur de Alta Especialidad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Md', 'investigatorFullName': 'Jorge Yanez', 'investigatorAffiliation': 'Hospital Central Sur de Alta Especialidad'}}}}