StrokeNCT04072120
Stroke Survival in Municipalities: Impact of Geographic Proximity to First- and Second-degree Relatives
An observational study of Stroke, run by University of Oslo at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Stroke
- How many people
- 7,400,000 participants
- Where
- 1 siteNorway
- Study dates
- 15 Aug 2019to 14 Aug 2022
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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. 2. The Multigenerational Register in Statistics Norway covering family linkage on all individuals to their parents for all born after 1952 is included. 3. The Census from 1960, and from 1970 to 2011 4. Hospital data on hospital discharge from cardiovascular events among all Norwegians from 1992.
Who may be able to join
- Norwegian citizens aged 45 and above 1.1.1994 - 31.12. 2009 and had stroke events
- Those who attend a cardiovascular health survey who later developed stroke.
- All Norwegians born in the period 1 January 1940 to 31 December 1959 who survived to 1991
- Norwegian citizens aged 45 and above 1.1.2016 and had stroke events
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Community Medicine and Global Health,University of Oslo
Oslo, 0450
About this study
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.
- Conditions
- Stroke
- Keywords
- Stroke, Post-acute stroke, Geographical proximity, Family, Relatives, Survival analysis
- Medical subject headings
- 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 |
|---|---|---|
| R1 | 1. Norwegian citizens aged 45 and above 1.1.1994 - 31.12. 2009 registered in the FS-data during this period. 2. Sub-sample those attending a cardiovascular health survey who later developed stroke. | |
| R2 | All Norwegians born in the period 1 January 1940 to 31 December 1959 who survived to 1991. | |
| R3 | Norwegian citizens aged 45 and above 1.1.2016. |
What is being measured
The primary outcome is the main question the study is designed to answer.
R1- Mortality
Mortality of Norwegian citizens aged 45 and above 1.1.1994 - 31.12. 2009
Measured: Mortality follow-up from 1.1.1994 to 31.12.2014
R2- Mortality
Mortality of all Norwegians born in the period 1 January 1940 to 31 December 1959 who survived to 1991
Measured: Mortality follow-up from 1991-2014.
R3- Stroke events
Norwegian citizens aged 45 and above 1.1.2016
Measured: Stroke events registered in the Patient registry after 2016, (possibly until 2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start15 Aug 2019
- Primary completion14 Aug 2022 (estimated)
- Study completion14 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 7,400,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Extrastiftelsen, The National Association for Public Health, Norway
- Responsible party
- Principal investigator, CHOI, HYE JUNG, University of Oslo
- Investigators
- Øyvind Næss, MD, MSc, PhD, Principal investigator, Department of Community Medicine and Global Health, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072120
- Sponsor's protocol ID
- NorStrokeSurvival
- Status last verified
- May 2020
- First submitted
- 22 Aug 2019
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Survival in Municipalities: Impact of Geographic Proximity to First- and Second-degree Relatives
- ClinicalTrials.gov ID
- NCT04072120
- Acronym / sponsor ID
- NorStrokeSurvival
- Conditions
- Stroke
- Keywords
- Stroke, Post-acute stroke, Geographical proximity, Family, Relatives, Survival analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,400,000 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Extrastiftelsen, The National Association for Public Health, Norway
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 14 Aug 2022 (estimated)
- Study completion
- 14 Aug 2022 (estimated)
- First posted
- 28 Aug 2019 (actual)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| R1 | – | –1. Norwegian citizens aged 45 and above 1.1.1994 - 31.12. 2009 registered in the FS-data during this period. 2. Sub-sample those attending a cardiovascular health survey who later developed stroke. |
| R2 | – | –All Norwegians born in the period 1 January 1940 to 31 December 1959 who survived to 1991. |
| R3 | – | –Norwegian citizens aged 45 and above 1.1.2016. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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. 2. The Multigenerational Register in Statistics Norway covering family linkage on all individuals to their parents for all born after 1952 is included. 3. The Census from 1960, and from 1970 to 2011 4. Hospital data on hospital discharge from cardiovascular events among all Norwegians from 1992.
Key inclusion criteria (4 listed)
- Norwegian citizens aged 45 and above 1.1.1994 - 31.12. 2009 and had stroke events
- Those who attend a cardiovascular health survey who later developed stroke.
- All Norwegians born in the period 1 January 1940 to 31 December 1959 who survived to 1991
- Norwegian citizens aged 45 and above 1.1.2016 and had stroke events
Key exclusion criteria (1 listed)
- -
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
R1- Mortality
Time frame: Mortality follow-up from 1.1.1994 to 31.12.2014
Mortality of Norwegian citizens aged 45 and above 1.1.1994 - 31.12. 2009
R2- Mortality
Time frame: Mortality follow-up from 1991-2014.
Mortality of all Norwegians born in the period 1 January 1940 to 31 December 1959 who survived to 1991
R3- Stroke events
Time frame: Stroke events registered in the Patient registry after 2016, (possibly until 2019)
Norwegian citizens aged 45 and above 1.1.2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
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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.
Øyvind Næss, MD, MSc, PhD principal investigator
Department of Community Medicine and Global Health, University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Oslo at 1 site in Norway.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Results are not available in the source record.
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?
R1- Mortality (time frame: Mortality follow-up from 1.1.1994 to 31.12.2014). The study lists 3 primary outcomes in all. 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 15 May 2020.