Cardiovascular DiseasesSoPPNCT02212145
Follow-up of Sollentuna Prevention Program
An observational study of Cardiovascular Diseases, run by Karolinska Institutet.
Trial summary
To evaluate long-term effects of one individual- and population-oriented cardiovascular prevention programs in primary care. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 1,600,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 1988to Dec 2016
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age < 15 years
About this study
Official title: Long-term Follow-up of an Individual and Population-based Program Aimed at Preventing Cardiovascular Disease in Sollentuna Municipality
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.
- 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.
- 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.
- 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.
- Conditions
- Cardiovascular Diseases
- Keywords
- prevention, cardiovascular disease, risk factors
- Medical subject headings
- Cardiovascular Diseases
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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 24 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startJun 1988
- Primary completionSep 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 1,600,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Heart Lung Foundation
- Responsible party
- Principal investigator, Mai-Lis Hellénius, Professor, Karolinska Institutet
- Investigators
- Gunilla Journath, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212145
- Sponsor's protocol ID
- 20100473
- Other IDs
- 2012/1172-31/1
- Acronym
- SoPP
- Status last verified
- Jan 2015
- First submitted
- 7 Aug 2014
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up of an Individual and Population-based Program Aimed at Preventing Cardiovascular Disease in Sollentuna Municipality
- ClinicalTrials.gov ID
- NCT02212145
- Acronym / sponsor ID
- SoPP / 20100473
- Conditions
- Cardiovascular Diseases
- Keywords
- prevention, cardiovascular disease, risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,600,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Swedish Heart Lung Foundation
- Study start
- Jun 1988
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 8 Aug 2014 (estimated)
- 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.
To evaluate long-term effects of one individual- and population-oriented cardiovascular prevention programs in primary care.
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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Age < 15 years
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
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
Long term follow-up of a cardiovascular prevention program by using Swedish national patient registries
1 secondary outcome
A follow-up of drug treatment of diabetes, dyslipidemia and hypertension
Time frame: 24 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
- Derived from this study: PubMed 26580968Journath 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.
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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.
Gunilla Journath, PhD principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Karolinska Institutet.
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 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02212145, which also lists 1 linked publication.
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 21 Jan 2015; AzTrials last refreshed its copy on 3 Nov 2026.