Socioeconomic StatusNCT04199663
Socioeconomic Status, Secondary Prevention Activities and Recurrence After a Myocardial Infarction
An observational study of Socioeconomic Status and Secondary Prevention, run by Karolinska Institutet.
Trial summary
This is a nationwide cohort study on real-world patients (n≈30,000) surviving a first myocardial infarction (MI) 2006-2013 and alive to attend a routine 1-year follow-up. Associations between Socioeconomic Status (SES) and secondary preventive actions (SPAs) throughout the first year is studied and assessed as… Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Socioeconomic Status, Secondary Prevention, Myocardial Infarction
- How many people
- 30,191 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2006to 31 Dec 2018
- How long will I take part?
- 88 Months
- 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 18 to 76 years
- All sexes
- Adult, Older adult
Study population: large nation-wide population of consecutive patients with assumed stable coronary heart disease after a myocardial infarction (first manifestation of atherosclerotic cardiovascular disease) in a tax-funded health care system.
Who may be able to join
- Swedish resident
- Alive and registered in The Swedish Websystem for Enhancement and Development of Evidence based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART)'s secondary prevention subregistry between 1 January 2006 and 31 December 2013 at the 1-year-revisit
Who cannot join
- Age >76 years at baseline
- Missing data for disposable household income
- History of MI, stroke, coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) prior to the index MI
- Not present in initial care registry (RiksHIA)
- Date of index MI before 2004 or missing
- revisit outside 13±2 month window post-MI
About this study
Official title: Secondary Prevention Treatments and Activities Post Myocardial Infarction Underlying the Risk of Recurrent Hard Cardiovascular Outcomes Associated With Socioeconomic Status
This is a nationwide cohort study on real-world patients (n≈30,000) surviving a first myocardial infarction (MI) 2006-2013 and alive to attend a routine 1-year follow-up. Associations between Socioeconomic Status (SES) and secondary preventive actions (SPAs) throughout the first year is studied and assessed as possible mechanisms underlying the increased risk of a first recurrent hard cardiocvascular (CV) outcome, recurrent atherosclerotic cardiovascular disease (rASCVD), in patients with low Socioeconomic Status during long-term follow-up (2006-2018).
- Conditions
- Socioeconomic Status, Secondary Prevention, Myocardial Infarction, Cardiovascular Disease, Stroke
- Medical subject headings
- Myocardial Infarction, Cardiovascular Diseases, Stroke
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 |
|---|---|---|
| categories of Socioeconomic Status (SES) | by proxy gender- and calendar year-specific quintiles of disposable income per household consumption unit. In logistic regression models of associations with secondary prevention activities and established treatment goals: highest vs. lowest income quintile. In multivariable Cox regression analyses with stepwise built models: quintiles of disposable income and models including covariates level of education and marital status. |
What is being measured
The primary outcome is the main question the study is designed to answer.
first recurrent atherosclerotic cardiovascular disease event (rASCVD)
composite outcome including non-fatal MI (I210-I214, I219, I220, I221, I228 or I229) or coronary heart disease death (CHD) (I210-I214, I219, I220, I221, I228, I229, I461 or I469) or fatal or non-fatal ischemic stroke (I630-I635, I638 or I639) according to the International Classification of Diseases 10th edition (ICD-10)
Measured: from date of 1-year visit post-MI (baseline) until date of outcome, censoring or study end (2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start1 Jan 2006
- Primary completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Socioeconomic StatusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,191 participants (actual)
- Target duration
- 88 Months
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Svensson, Karolinska Institutet
- Investigators
- Per O Svensson, MD PhD, Principal investigator, Department of Clinical Science and Education, Söderjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199663
- Sponsor's protocol ID
- 3
- Status last verified
- Feb 2020
- First submitted
- 12 Dec 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention Treatments and Activities Post Myocardial Infarction Underlying the Risk of Recurrent Hard Cardiovascular Outcomes Associated With Socioeconomic Status
- ClinicalTrials.gov ID
- NCT04199663
- Acronym / sponsor ID
- 3
- Conditions
- Socioeconomic Status, Secondary Prevention, Myocardial Infarction, Cardiovascular Disease, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,191 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- First posted
- 16 Dec 2019 (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.
This is a nationwide cohort study on real-world patients (n≈30,000) surviving a first myocardial infarction (MI) 2006-2013 and alive to attend a routine 1-year follow-up. Associations between Socioeconomic Status (SES) and secondary preventive actions (SPAs) throughout the first year is studied and assessed as possible mechanisms underlying the increased risk of a first recurrent hard cardiocvascular (CV) outcome, recurrent atherosclerotic cardiovascular disease (rASCVD), in patients with low Socioeconomic Status during long-term follow-up (2006-2018).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 88 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| categories of Socioeconomic Status (SES) | – | –by proxy gender- and calendar year-specific quintiles of disposable income per household consumption unit. In logistic regression models of associations with secondary prevention activities and established treatment goals: highest vs. lowest income quintile. In multivariable Cox regression analyses with stepwise built models: quintiles of disposable income and models including covariates level of education and marital status. |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- large nation-wide population of consecutive patients with assumed stable coronary heart disease after a myocardial infarction (first manifestation of atherosclerotic cardiovascular disease) in a tax-funded health care system.
Key inclusion criteria (2 listed)
- Swedish resident
- Alive and registered in The Swedish Websystem for Enhancement and Development of Evidence based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART)'s secondary prevention subregistry between 1 January 2006 and 31 December 2013 at the 1-year-revisit
Key exclusion criteria (6 listed)
- Age >76 years at baseline
- Missing data for disposable household income
- History of MI, stroke, coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) prior to the index MI
- Not present in initial care registry (RiksHIA)
- Date of index MI before 2004 or missing
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
first recurrent atherosclerotic cardiovascular disease event (rASCVD)
Time frame: from date of 1-year visit post-MI (baseline) until date of outcome, censoring or study end (2018)
composite outcome including non-fatal MI (I210-I214, I219, I220, I221, I228 or I229) or coronary heart disease death (CHD) (I210-I214, I219, I220, I221, I228, I229, I461 or I469) or fatal or non-fatal ischemic stroke (I630-I635, I638 or I639) according to the International Classification of Diseases 10th edition (ICD-10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
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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.
Per O Svensson, MD PhD principal investigator
Department of Clinical Science and Education, Söderjukhuset
Questions about this trial
What is this clinical trial studying?
An observational study of Socioeconomic Status and Secondary Prevention, 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 20 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
first recurrent atherosclerotic cardiovascular disease event (rASCVD) (time frame: from date of 1-year visit post-MI (baseline) until date of outcome, censoring or study end (2018)). 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 20 Feb 2020.