Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT04072120
Status:
UNKNOWN
Last Update Posted:
2020-05-15
First Post:
2019-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stroke Survival in Municipalities: Impact of Geographic Proximity to First- and Second-degree Relatives
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7400000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-08-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-13', 'studyFirstSubmitDate': '2019-08-22', 'studyFirstSubmitQcDate': '2019-08-27', 'lastUpdatePostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'R1- Mortality', 'timeFrame': 'Mortality follow-up from 1.1.1994 to 31.12.2014', 'description': 'Mortality of Norwegian citizens aged 45 and above 1.1.1994 - 31.12. 2009'}, {'measure': 'R2- Mortality', 'timeFrame': 'Mortality follow-up from 1991-2014.', 'description': 'Mortality of all Norwegians born in the period 1 January 1940 to 31 December 1959 who survived to 1991'}, {'measure': 'R3- Stroke events', 'timeFrame': 'Stroke events registered in the Patient registry after 2016, (possibly until 2019)', 'description': 'Norwegian citizens aged 45 and above 1.1.2016'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Post-acute stroke', 'Geographical proximity', 'Family', 'Relatives', 'Survival analysis'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Our key objective will be to investigate if geographic proximity to first- and second-degree relatives has an influence on post-acute stroke survival and use of health and social services. We will also model and map spatial variation in stroke and cardiovascular disease (CVD) incidence and mortality and see if some of the variation is due to spatial clustering of familial risk. The study will use innovative approaches to large-scale registry and survey data and statistical analysis on the full Norwegian population. We will integrate multigenerational and geographical information. This will enable us to assess key determinants on stroke survival and use of health and social care at municipality level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '1. All Norwegian residents in the period from 1960 to 2017 (n=7,4 mill), including all births and deaths(from the Cause of Death Registry) occurring in this population from 1960 onwards.\n2. The Multigenerational Register in Statistics Norway covering family linkage on all individuals to their parents for all born after 1952 is included.\n3. The Census from 1960, and from 1970 to 2011\n4. Hospital data on hospital discharge from cardiovascular events among all Norwegians from 1992.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Norwegian citizens aged 45 and above 1.1.1994 - 31.12. 2009 and had stroke events\n* Those who attend a cardiovascular health survey who later developed stroke.\n* All Norwegians born in the period 1 January 1940 to 31 December 1959 who survived to 1991\n* Norwegian citizens aged 45 and above 1.1.2016 and had stroke events\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04072120', 'briefTitle': 'Stroke Survival in Municipalities: Impact of Geographic Proximity to First- and Second-degree Relatives', 'organization': {'class': 'OTHER', 'fullName': 'University of Oslo'}, 'officialTitle': 'Stroke Survival in Municipalities: Impact of Geographic Proximity to First- and Second-degree Relatives', 'orgStudyIdInfo': {'id': 'NorStrokeSurvival'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'R1', 'description': '1. Norwegian citizens aged 45 and above 1.1.1994 - 31.12. 2009 registered in the FS-data during this period.\n2. Sub-sample those attending a cardiovascular health survey who later developed stroke.'}, {'label': 'R2', 'description': 'All Norwegians born in the period 1 January 1940 to 31 December 1959 who survived to 1991.'}, {'label': 'R3', 'description': 'Norwegian citizens aged 45 and above 1.1.2016.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '0450', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Department of Community Medicine and Global Health,University of Oslo', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Øyvind Næss, MD, MSc, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Community Medicine and Global Health, University of Oslo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oslo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Extrastiftelsen', 'class': 'OTHER'}, {'name': 'The National Association for Public Health, Norway', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctoral Research Fellow', 'investigatorFullName': 'CHOI, HYE JUNG', 'investigatorAffiliation': 'University of Oslo'}}}}