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Completed

NCT Number: NCT04199663

Socioeconomic Status, Secondary Prevention Activities and Recurrence After a Myocardial Infarction

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).

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Key information

Conditions

Socioeconomic Status Brain Diseases Cardiovascular Disease Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Secondary Prevention Stroke Vascular Diseases

Age range

18 year–76 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Other outcomes

  1. Goal: physical training program

    Time frame: at 1-year revisit

    participated in organized physical training program after the initial care

  2. Goal: LDL-C goal

    Time frame: at 1-year revisit

    attained LDL-C level below treatment target

  3. Goal: Blood pressure goal

    Time frame: at 1-year revisit

    attained blood pressure levels below treatment target

  4. Goal: smoking cessation

    Time frame: at 1-year revisit

    Patients being current smokers at their initial care who successfully quit smoking.

  5. Goal: physical activity

    Time frame: at 1-year revisit

    reported >30 minutes of physical activity ≥5 times a week

  6. Goal: statin treatment

    Time frame: at 1-year revisit

    on statin treatment 1 year after the index MI

  7. Goal: Renin-angiotensin-aldosteron system (RAAS)-inhibition

    Time frame: at 1-year revisit

    Patients with congestive heart failure, diabetes or hypertension at the index Mi on treatment with angiotensin converting enzyme inhibitor or angiotensin receptor blocker.

  8. Goal: HbA1c goal

    Time frame: at 1-year revisit

    Patients with diabetes with attained HbA1c treatment target

  9. SPA: cardiac rehabilitation program

    Time frame: during 1st year after initial care

    participation in structured program after the index MI

  10. SPA: diet course

    Time frame: during 1st year after initial care

    participation in course after the index MI

  11. SPA: statin intensity increase

    Time frame: 2 months or 1 year after initial care

    statin intensity increase decided at routine revisits (Dosages categorized into high (Rosuvastatin 20-40 mg or Atorvastatin 40-80 mg), moderate (Rosuvastatin 5-10 mg, Atorvastatin 10-20 mg, or Simvastatin 20-40 mg) and low (Simvastatin 10 mg))

  12. SPA: high intensity statins

    Time frame: at 1-year revisit

    on high intensity statin treatment (Rosuvastatin 20-40 mg or Atorvastatin 40-80 mg)

  13. SPA: LDL-C reduction

    Time frame: 2 months and 1 year after initial care

    LDL-C reduction between routine revisits

  14. SPA: lipid monitoring

    Time frame: 2 months or 1 year after initial care

    Blood lipid panel measured

  15. SPA: type of follow-up

    Time frame: 2 month revisit

    decided follow-up by office revisit or by phone

  16. SPA: reperfusion

    Time frame: initial care

    type of reperfusion treatment chosen in STEMI and NSTEMI

  17. SPA: revascularized

    Time frame: initial care

    achieved complete revascularization in STEMI and NSTEMI

  18. SPA: staged procedure

    Time frame: initial care

    Decision on continued invasive procedures at a later stage

  19. SPA: smoking cessation counseling

    Time frame: 2 months or 1 year after initial care

    received through cessation program or counseling

  20. SPA: HbA1c monitoring

    Time frame: during initial care, at 2 months and 1 year after initial care

    Patients with diabetes at initial care having their HbA1c measured at least twice

  21. SPA: Anti-stress program

    Time frame: 1 year after initial care

    Patients reporting anxiety or sadness participating in anti-stress program

  22. SPA: counter-metabolic syndrome actions

    Time frame: 2 months or 1 year after initial care

    Patients with the metabolic syndrome participating in physical training and diet course or in cardiac rehabilitation program

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Secondary Prevention Treatments and Activities Post Myocardial Infarction Underlying the Risk of Recurrent Hard Cardiovascular Outcomes Associated With Socioeconomic Status

Important dates

Study start
2006
Primary completion
2018
First posted
Dec 16, 2019
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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