Cardiovascular DiseasesNSHDSNCT03426488
Northern Sweden Health and Disease Study
An observational study of Cardiovascular Diseases and Cancer, run by Umeå University at 1 site in Sweden.
Trial summary
NSHDS (Northern Sweden Health and Disease Study) is an umbrella term for a prospective biobank with related survey data. The sample collection consists of three subcohorts, Västerbotten Intervention Programme (VIP), Mammography Screening Project (MA) and MONICA (MONItoring of Trends and Determinants in CArdiovascular… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Cancer, Neurodegenerative Diseases
- What is being tested?
- VIP - Västerbotten Intervention Programme
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120,000 participants
- Where
- 1 siteSweden
- Study dates
- Jan 1986to Jan 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Given before
Who may be able to join
- Residents in Northern Sweden
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Umeå University
Umeå, Västerbotten County, 90187
Lena Jakobsson, Coordinator, +46907858643, lena.jakobsson@umu.se
Åsa Ågren, Databasehead, +46907852862, asa.agren@umu.se
About this study
NSHDS (Northern Sweden Health and Disease Study) is an umbrella term for a prospective biobank with related survey data. The sample collection consists of three subcohorts, Västerbotten Intervention Programme (VIP), Mammography Screening Project (MA) and MONICA (MONItoring of Trends and Determinants in CArdiovascular Disease). The blood samples are stored at the Northern Sweden Biobank.
Read the detailed description
The overall aim of the NSHDS is to support frontline research with particular emphasis on improving diagnostic tools for clinical use, as well as finding early markers of disease, using the blood samples, tissue and associated health data from the NSHDS. Furthermore, basic research regarding risk factors as well as pathogenetic pathways are promoted.
The prospective blood samples and related survey data can be linked to national registries for health outcomes such as cancer diagnosis for which there is a near 100% completeness of the data.
VIP - VÄSTERBOTTEN INTERVENTION PROGRAMME The VIP is a long-term project intended for health promotion of the population of the county of Västerbotten (approximately 254,000 inhabitants). All individuals 40, 50, and 60 years of age in the county are invited for screening. They are asked to complete a questionnaire concerning various lifestyle factors, including diet, and to donate a blood sample to be frozen for later research purposes. The cohort is population-based and the inclusion of individuals started 1985 and is ongoing. The participation rate has ranged between 48 and 67% of the population. But a large number has not been invited for screening. Among those invited the participation rate has been very high. The material is population based.
The blood samples consist primarily of EDTA (ethylenediaminetetraacetic acid) and heparin blood samples divided into plasma, erythrocyte concentrate and buffy coat. Questionnaire data are linked to blood samples.
The majority of samples are fasting samples. Number of individuals: 103,100 Individuals with repeated samples: 43,500 Sampling occasions: 151,200 (October 2016)
MA - MAMMOGRAPHY SCREENING PROJECT
Samples and data are collected in connection with mammography screenings 1995-2006. The blood samples consist primarily of EDTA and heparin blood samples divided into plasma, erythrocyte concentrate and buffy coat, and for a certain percentage, the DNA is also extracted. The cohort consists of women, 18-82 years old (95% between 48 and 70 years old).
Survey data can be linked to the blood samples.
Individuals: 28,800 Individuals with repeated samples: 14,600 Sampling occasions: 54,000
THE MONICA STUDY
The MONICA study is a longitudinal population-based database for research in cardiovascular disease and diabetes. Since 1985, seven screenings has been performed (1986, 1990, 1994, 1999, 2004, 2009 and 2014) of a randomized selection of the population in the counties of Västerbotten and Norrbotten in Northern Sweden.
Individuals: 11,800 Individuals with repeated samples: 3,500 Sampling occasions: 15,300
This registration will only cover blood sampling (screenings since 1990) and dietary data (optional MONICA study, screenings since 1986) as a part of the National Environmental Biobank. The participation rates have been 69-81%.
A separate registration is expected for the basic MONICA study.
- Conditions
- Cardiovascular Diseases, Cancer, Neurodegenerative Diseases, Respiratory Disease, Infection
- Being tested
- VIP - Västerbotten Intervention Programme
- Medical subject headings
- Cardiovascular Diseases, Neoplasms, Neurodegenerative Diseases, Respiration Disorders, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIP - Västerbotten Intervention ProgrammeBehavioural
Intervention on CVD (cardiovascular disease) and diabetes
| Study group | Role | What they receive |
|---|---|---|
| Västerbotten Intervention Programme | The cohort is population-based and consists of blood and data from primarily 40, 50 and 60 year olds, taken every year in this age group in connection with the Västerbotten health surveys from 1985 - present.
The blood samples consist primarily of EDTA and heparin blood samples divided into plasma, erythrocyte concentrate and buffy coat and for a certain percentage, the DNA is extracted.
The database NSDD (Northern Sweden Diet Database) consists of survey data from VIP concerning nutritional factors.
A large part is fasting samples.
Individuals: 105,700 Individuals with repeated samples: 40,700 Sampling occasions: 156,300 Receives: Behavioral: VIP - Västerbotten Intervention Programme | |
| Mammography Screening Project | Samples and data are collected in connection with mammography screenings 1995-2006. The blood samples consist primarily of EDTA and heparin blood samples divided into plasma, erythrocyte concentrate and buffy coat, and for a certain percentage, the DNA is also extracted. The cohort consists of women, 18-82 years old (95% between 48 and 70 years old). Survey data can be linked to the blood samples. Individuals: 28,800 Individuals with repeated samples: 14,600 Sampling occasions: 54,000 | |
| The Northern Swedish MONICA Project | The MONICA study is a longitudinal population-based database for research in cardiovascular disease and diabetes. Since 1985, seven screenings has been performed (1986, 1990, 1994, 1999, 2004, 2009 and 2014) of a randomized selection of the population in the counties of Västerbotten and Norrbotten in Northern Sweden. Individuals: 11,800 Individuals with repeated samples: 3,500 Sampling occasions: 15,300 (March 2015) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of deaths
Measured: Follow up at least 20 years
Numbers of incident cases of disease.
Measured: Follow up at least 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study startJan 1986
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 120,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Göran Hallmans, MD PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426488
- Sponsor's protocol ID
- Umu
- Acronym
- NSHDS
- Status last verified
- Dec 2017
- First submitted
- 18 Dec 2017
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Northern Sweden Health and Disease Study
- ClinicalTrials.gov ID
- NCT03426488
- Acronym / sponsor ID
- NSHDS / Umu
- Conditions
- Cardiovascular Diseases, Cancer, Neurodegenerative Diseases, Respiratory Disease, Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120,000 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Jan 1986 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 8 Feb 2018 (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.
NSHDS (Northern Sweden Health and Disease Study) is an umbrella term for a prospective biobank with related survey data. The sample collection consists of three subcohorts, Västerbotten Intervention Programme (VIP), Mammography Screening Project (MA) and MONICA (MONItoring of Trends and Determinants in CArdiovascular Disease). The blood samples are stored at the Northern Sweden Biobank.
Detailed description
The overall aim of the NSHDS is to support frontline research with particular emphasis on improving diagnostic tools for clinical use, as well as finding early markers of disease, using the blood samples, tissue and associated health data from the NSHDS. Furthermore, basic research regarding risk factors as well as pathogenetic pathways are promoted.
The prospective blood samples and related survey data can be linked to national registries for health outcomes such as cancer diagnosis for which there is a near 100% completeness of the data.
VIP - VÄSTERBOTTEN INTERVENTION PROGRAMME The VIP is a long-term project intended for health promotion of the population of the county of Västerbotten (approximately 254,000 inhabitants). All individuals 40, 50, and 60 years of age in the county are invited for screening. They are asked to complete a questionnaire concerning various lifestyle factors, including diet, and to donate a blood sample to be frozen for later research purposes. The cohort is population-based and the inclusion of individuals started 1985 and is ongoing. The participation rate has ranged between 48 and 67% of the population. But a large number has not been invited for screening. Among those invited the participation rate has been very high. The material is population based.
The blood samples consist primarily of EDTA (ethylenediaminetetraacetic acid) and heparin blood samples divided into plasma, erythrocyte concentrate and buffy coat. Questionnaire data are linked to blood samples.
The majority of samples are fasting samples. Number of individuals: 103,100 Individuals with repeated samples: 43,500 Sampling occasions: 151,200 (October 2016)
MA - MAMMOGRAPHY SCREENING PROJECT
Samples and data are collected in connection with mammography screenings 1995-2006. The blood samples consist primarily of EDTA and heparin blood samples divided into plasma, erythrocyte concentrate and buffy coat, and for a certain percentage, the DNA is also extracted. The cohort consists of women, 18-82 years old (95% between 48 and 70 years old).
Survey data can be linked to the blood samples.
Individuals: 28,800 Individuals with repeated samples: 14,600 Sampling occasions: 54,000
THE MONICA STUDY
The MONICA study is a longitudinal population-based database for research in cardiovascular disease and diabetes. Since 1985, seven screenings has been performed (1986, 1990, 1994, 1999, 2004, 2009 and 2014) of a randomized selection of the population in the counties of Västerbotten and Norrbotten in Northern Sweden.
Individuals: 11,800 Individuals with repeated samples: 3,500 Sampling occasions: 15,300
This registration will only cover blood sampling (screenings since 1990) and dietary data (optional MONICA study, screenings since 1986) as a part of the National Environmental Biobank. The participation rates have been 69-81%.
A separate registration is expected for the basic MONICA study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Västerbotten Intervention Programme | – | Behavioral: VIP - Västerbotten Intervention ProgrammeThe cohort is population-based and consists of blood and data from primarily 40, 50 and 60 year olds, taken every year in this age group in connection with the Västerbotten health surveys from 1985 - present. The blood samples consist primarily of EDTA and heparin blood samples divided into plasma, erythrocyte concentrate and buffy coat and for a certain percentage, the DNA is extracted. The database NSDD (Northern Sweden Diet Database) consists of survey data from VIP concerning nutritional factors. A large part is fasting samples. Individuals: 105,700 Individuals with repeated samples: 40,700 Sampling occasions: 156,300 |
| Mammography Screening Project | – | –Samples and data are collected in connection with mammography screenings 1995-2006. The blood samples consist primarily of EDTA and heparin blood samples divided into plasma, erythrocyte concentrate and buffy coat, and for a certain percentage, the DNA is also extracted. The cohort consists of women, 18-82 years old (95% between 48 and 70 years old). Survey data can be linked to the blood samples. Individuals: 28,800 Individuals with repeated samples: 14,600 Sampling occasions: 54,000 |
| The Northern Swedish MONICA Project | – | –The MONICA study is a longitudinal population-based database for research in cardiovascular disease and diabetes. Since 1985, seven screenings has been performed (1986, 1990, 1994, 1999, 2004, 2009 and 2014) of a randomized selection of the population in the counties of Västerbotten and Norrbotten in Northern Sweden. Individuals: 11,800 Individuals with repeated samples: 3,500 Sampling occasions: 15,300 (March 2015) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Given before
Key inclusion criteria (1 listed)
- Residents in Northern Sweden
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIP - Västerbotten Intervention ProgrammeIntervention on CVD (cardiovascular disease) and diabetes | Behavioural | Västerbotten Intervention Programme |
Primary outcome
Number of deaths
Time frame: Follow up at least 20 years
Numbers of incident cases of disease.
Time frame: Follow up at least 20 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Göran Hallmans, MD PhD principal investigator
Umeå University
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 Cardiovascular Diseases and Cancer, run by Umeå University at 1 site in Sweden.
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 1 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 8 Feb 2018. 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 Sweden. 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?
Contact Göran Hallmans, MD, PhD (+46706382516, goran.hallmans@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of deaths (time frame: Follow up at least 20 years). The study lists 2 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 8 Feb 2018.