This trial is active, not recruiting.

Condition cardiovascular diseases
Sponsor Karolinska Institutet
Collaborator Swedish Heart Lung Foundation
Start date June 1988
End date September 2015
Trial size 1600000 participants
Trial identifier NCT02212145, 20100473, 2012/1172-31/1


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model ecologic or community
Time perspective retrospective
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 individuals included in the screened group, who lived in Stockholm County at least during one year at the time of the intervention.
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.

Primary Outcomes

Incidence and mortality in acute myocardial infarction, stroke, cardiovascular disease, and overall mortality, a twenty year follow-up of a prevention program.
time frame: 24 years

Secondary Outcomes

A follow-up of drug treatment of diabetes, dyslipidemia and hypertension
time frame: 24 years

Eligibility Criteria

Male or female participants at least 15 years old.

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

Additional Information

Official title Long-term Follow-up of an Individual and Population-based Program Aimed at Preventing Cardiovascular Disease in Sollentuna Municipality
Principal investigator Gunilla Journath, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Karolinska Institutet.