ClinicalTrials.gg
Status unknownNCT02212145SoPPUpdated Jan 21, 2015

Follow-up of Sollentuna Prevention Program

An observational study in Cardiovascular Diseases, sponsored by Karolinska Institutet. Status unknown. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-21.

Sponsored by Karolinska Institutet · Observational

The sponsor has not verified this record recently (last verified Jan 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Ecologic or community
Time perspective
Retrospective
Enrollment
1,600,000
Ages
15 Years and older
Sex
All
01

Study summary

To evaluate long-term effects of one individual- and population-oriented cardiovascular prevention programs in primary care.

Read the detailed description

In Sweden there are unique opportunities to create a relevant comparison group for this study, which is of great importance to the value of this cohort study.

Of the three study populations two (2-3)will be created by using national registries.

  1. The screened group consists of the individuals (n = 5938) who had direct contact with the prevention program, ie undergone a voluntary opportunistic cardiovascular screening (questionnaire, physical examination and testing in connection with visits to health centers) and the rest of all individuals who lived in Sollentuna Municipality between 1988-1993.
  2. Relatives of individuals included in the screened group who lived in Stockholm county at the time of the intervention will be identified by the use of the Medical Birth Register and the Multi-Generation Register. Family members are defined as parents, siblings and children and husband / wife to those in thescreened group and will be analyzed in the same way as those who participated in the intervention for risk of developing cardiovascular disease and cancer.
  3. The comparison group consists of the entire population of Stockholm County minus Sollentuna 1988-93, taking into account population changes (migration, birth, death) during the period.

This three populations will be followed-up in national registries and databases

All subjects will be monitored for example disease history, socio-economics and biochemical risk factors presented below national registries and research databases. When all the matches of national registers and a local register (AMORIS)have been done the database will de-identified and anonymized data to be available for statistical processing.

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Conditions studied

  • Cardiovascular Diseases

Keywords

  • prevention
  • cardiovascular disease
  • risk factors
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In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

This study's planned enrollment of 1,600,000 is above the median of 600 across 1,524 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,146 studies on the registry; 275 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

  1. The screened group who participated in the cardiovascular prevention program:

    (n=5938) and the rest of the population in Sollentuna Municipality.

  2. To the screened group matched "controls" will be selected randomly from the population of Stockholm County minus Sollentuna. The population in Sollentuna will compared to the population of Stockholm County minus Sollentuna Municipality.
  3. Relatives of individuals included in the intervention group and who lived in Stockholm County at the time of the intervention will be identified by use of national registers.

Eligibility criteria

Inclusion Criteria in the risk intervention group:

  • Individuals 15 years of age or more who visited three (four) health care centres in Sollentuna 1988-1993 were offered to participate in the prevention program

Exclusion Criteria in the screened intervention group:

  • Age \< 15 years
05

Study design

Observational model
Ecologic or community
Time perspective
Retrospective
Enrollment
1,600,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Screened group

    Screened group is defined as those individuals who were willing to participate in the cardiovascular prevention program and all the individuals who lived in Sollentuna during the intervention.

  • Relatives to the screened group

    Relatives to individuals included in the screened group, who lived in Stockholm County at least during one year at the time of the intervention.

  • Control group

    Matched "controls" is going to be selected randomly from the population of Stockholm County minus Sollentuna Municipality with relevant background factors. The whole population will be used as a comparison group when evaluating the result from all the municipality of Sollentuna during 1988-1993.

06

What researchers measure

Primary outcomes

  1. Incidence and mortality in acute myocardial infarction, stroke, cardiovascular disease, and overall mortality, a twenty year follow-up of a prevention program.

    Long term follow-up of a cardiovascular prevention program by using Swedish national patient registries

    Time frame: 24 years

Secondary outcomes

  1. A follow-up of drug treatment of diabetes, dyslipidemia and hypertension

    By using the drug register in Sweden do a follow-up of drug treatment in the cohort

    Time frame: 24 years

Other outcomes

  1. Incidence and mortality in cancer

    Incidence and mortality in cancer - a twenty year follow-up by using the swedish cancer register

    Time frame: 24 years

  2. Consumption of medical care overall and for different diagnostic groups

    To study medical care consumption overall for different diagnostic groups by using different registers in Sweden

    Time frame: 24 years

  3. Health economic aspects

    Health economic aspects such as 1. health care consumption in total and for different diagnostic groups 2. care costs 3. impact on indirect costs (lost working years and sick leave) 4. intervention cost will be studied

    Time frame: 24 years

  4. Time trends of morbidity and mortality in acute myocardial infarction, stroke, cardiovascular disease and total mortality

    To study time trends of morbidity and mortality in acute myocardial infarction, stroke, cardiovascular disease and total mortality by use of National Swedish registries.

    Time frame: 24 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Journath G, Hammar N, Elofsson S, Linnersjo A, Vikstrom M, Walldius G, Krakau I, Lindgren P, de Faire U, Hellenius ML. Time Trends in Incidence and Mortality of Acute Myocardial Infarction, and All-Cause Mortality following a Cardiovascular Prevention Program in Sweden. PLoS One. 2015 Nov 18;10(11):e0140201. doi: 10.1371/journal.pone.0140201. eCollection 2015. PubMed 26580968 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02212145
Collaborators
Swedish Heart Lung Foundation
Responsible party
Mai-Lis Hellénius, Professor (Professor, Karolinska Institutet) — Principal investigator
First posted
Aug 8, 2014
Start date
Jun 1988
Primary completion
Sep 2015 (estimated)
Completion
Dec 2016 (estimated)
Last update
Jan 21, 2015

Study contacts

Gunilla Journath, PhD
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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