Clinical trial NCT04199663: Socioeconomic Status, Secondary Prevention Activities and Recurrence After a Myocardial Infarction
Official title: Secondary Prevention Treatments and Activities Post Myocardial Infarction Underlying the Risk of Recurrent Hard Cardiovascular Outcomes Associated With Socioeconomic Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Socioeconomic Status
Secondary Prevention
Myocardial Infarction
Cardiovascular Disease
Stroke
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 30191
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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 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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: first recurrent atherosclerotic cardiovascular disease event (rASCVD)
timeFrame: from date of 1-year visit post-MI (baseline) until date of outcome, censoring or study end (2018)
Secondary outcomes:
Other outcomes:
measure: Goal: physical training program
timeFrame: at 1-year revisit
measure: Goal: LDL-C goal
timeFrame: at 1-year revisit
measure: Goal: Blood pressure goal
timeFrame: at 1-year revisit
measure: Goal: smoking cessation
timeFrame: at 1-year revisit
measure: Goal: physical activity
timeFrame: at 1-year revisit
measure: Goal: statin treatment
timeFrame: at 1-year revisit
measure: Goal: Renin-angiotensin-aldosteron system (RAAS)-inhibition
timeFrame: at 1-year revisit
measure: Goal: HbA1c goal
timeFrame: at 1-year revisit
measure: SPA: cardiac rehabilitation program
timeFrame: during 1st year after initial care
measure: SPA: diet course
timeFrame: during 1st year after initial care
measure: SPA: statin intensity increase
timeFrame: 2 months or 1 year after initial care
measure: SPA: high intensity statins
timeFrame: at 1-year revisit
measure: SPA: LDL-C reduction
timeFrame: 2 months and 1 year after initial care
measure: SPA: lipid monitoring
timeFrame: 2 months or 1 year after initial care
measure: SPA: type of follow-up
timeFrame: 2 month revisit
measure: SPA: reperfusion
timeFrame: initial care
measure: SPA: revascularized
timeFrame: initial care
measure: SPA: staged procedure
timeFrame: initial care
measure: SPA: smoking cessation counseling
timeFrame: 2 months or 1 year after initial care
measure: SPA: HbA1c monitoring
timeFrame: during initial care, at 2 months and 1 year after initial care
measure: SPA: Anti-stress program
timeFrame: 1 year after initial care
measure: SPA: counter-metabolic syndrome actions
timeFrame: 2 months or 1 year after initial care
Locations:
Study officials:
affiliation: Department of Clinical Science and Education, Söderjukhuset
name: Per O Svensson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: