Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-16 @ 10:52 AM
Study NCT ID:
NCT03000959
Status:
UNKNOWN
Last Update Posted:
2016-12-22
First Post:
2016-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stroke Unit in the Philippines: Is it Effective
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 922}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-19', 'studyFirstSubmitDate': '2016-12-12', 'studyFirstSubmitQcDate': '2016-12-19', 'lastUpdatePostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality Rate', 'timeFrame': '3 Months'}], 'secondaryOutcomes': [{'measure': 'Functional outcome in modified rankin scale', 'timeFrame': '3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Stroke']}, 'referencesModule': {'references': [{'pmid': '22441195', 'type': 'BACKGROUND', 'citation': 'Langhorne P, de Villiers L, Pandian JD. Applicability of stroke-unit care to low-income and middle-income countries. Lancet Neurol. 2012 Apr;11(4):341-8. doi: 10.1016/S1474-4422(12)70024-8. Epub 2012 Mar 19.'}, {'type': 'BACKGROUND', 'citation': 'Werner Hacke. The stroke care revolution. Lancet 2014; 383: 176-85'}, {'pmid': '21571152', 'type': 'BACKGROUND', 'citation': 'Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.'}, {'pmid': '10097888', 'type': 'BACKGROUND', 'citation': 'Devuyst G, Bogousslavsky J. Clinical trial update: neuroprotection against acute ischaemic stroke. Curr Opin Neurol. 1999 Feb;12(1):73-9. doi: 10.1097/00019052-199902000-00012.'}, {'type': 'BACKGROUND', 'citation': 'Peter Langhorne,Martin Dennis. Stroke Units: An evidence based approach. BMJ Books. 1998'}, {'pmid': '7886733', 'type': 'BACKGROUND', 'citation': 'Counsell C, Warlow C, Sandercock P, Fraser H, van Gijn J. The Cochrane Collaboration Stroke Review Group. Meeting the need for systematic reviews in stroke care. Stroke. 1995 Mar;26(3):498-502.'}, {'type': 'BACKGROUND', 'citation': 'Dennis MS, Langhorne P. Stroke Units: An evidence based approach. London, BMJ Publishing, 1998: Chapter 4, 33-40.'}, {'type': 'BACKGROUND', 'citation': 'The Stroke Society of the Philippines (SSP) Handbook of Stroke. 6th edition. 2014, 220-227.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the effectiveness of Stroke Unit in the Philippines by comparing the functional outcome between those patient admitted in the general neurology wards and stroke units using modified Rankin Scale', 'detailedDescription': 'This study aims to look into functionality of patient admitted in the stroke unit in the Philippines'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all consecutive patients diagnosed with stroke (ischemic and hemorrhagic) starting on June 2016.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive patients admitted in participating SUs starting June 2016 during acute stroke (within 7 days from onset), either hemorrhagic or ischemic stroke confirmed by CT-Scan or MRI, will be included\n\nExclusion Criteria:\n\n* Patient who had previous of stroke and secondary cause of intracerebral hemorrhage such as trauma, arteriovenous malformation and aneurysm are not included in the study. Those who transferred from other institutions will be excluded. And also, patients who are below 18 years old are excluded in the study'}, 'identificationModule': {'nctId': 'NCT03000959', 'briefTitle': 'Stroke Unit in the Philippines: Is it Effective', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Jose R. Reyes Memorial Medical Center'}, 'officialTitle': 'Stroke Unit in the Philippines: Is it Effective?', 'orgStudyIdInfo': {'id': 'SU-PH1'}}, 'contactsLocationsModule': {'locations': [{'city': 'Maño', 'status': 'RECRUITING', 'country': 'Philippines', 'contacts': [{'name': 'Cyrus Escabillas', 'role': 'CONTACT', 'email': 'cyrusesca@gmail.com', 'phone': '7119491', 'phoneExt': '292'}, {'name': 'Cyrus Escabillas', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Jose R. Reyes Memorial Medical Center', 'geoPoint': {'lat': 11.04167, 'lon': 123.94472}}], 'overallOfficials': [{'name': 'Jose C Navarro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jose R. Reyes Memorial Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Computerized'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jose R. Reyes Memorial Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman Emeritus, Department of Neurology, Principal Investigator', 'investigatorFullName': 'Jose C. Navarro', 'investigatorAffiliation': 'Jose R. Reyes Memorial Medical Center'}}}}