NCT04072120

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,400,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2022

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

3 years

First QC Date

August 22, 2019

Last Update Submit

May 13, 2020

Conditions

Keywords

StrokePost-acute strokeGeographical proximityFamilyRelativesSurvival analysis

Outcome Measures

Primary Outcomes (3)

  • R1- Mortality

    Mortality of Norwegian citizens aged 45 and above 1.1.1994 - 31.12. 2009

    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

    Mortality follow-up from 1991-2014.

  • R3- Stroke events

    Norwegian citizens aged 45 and above 1.1.2016

    Stroke events registered in the Patient registry after 2016, (possibly until 2019)

Study Arms (3)

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.

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Community Medicine and Global Health,University of Oslo

Oslo, 0450, Norway

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Øyvind Næss, MD, MSc, PhD

    Department of Community Medicine and Global Health, University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Research Fellow

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 28, 2019

Study Start

August 15, 2019

Primary Completion

August 14, 2022

Study Completion

August 14, 2022

Last Updated

May 15, 2020

Record last verified: 2020-05

Locations