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

18. februar 2020 oppdatert av: Per Svensson, Karolinska Institutet

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).

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

30191

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 76 år (Voksen, Eldre voksen)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
first recurrent atherosclerotic cardiovascular disease event (rASCVD)
Tidsramme: 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)
from date of 1-year visit post-MI (baseline) until date of outcome, censoring or study end (2018)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Goal: physical training program
Tidsramme: at 1-year revisit
participated in organized physical training program after the initial care
at 1-year revisit
Goal: LDL-C goal
Tidsramme: at 1-year revisit
attained LDL-C level below treatment target
at 1-year revisit
Goal: Blood pressure goal
Tidsramme: at 1-year revisit
attained blood pressure levels below treatment target
at 1-year revisit
Goal: smoking cessation
Tidsramme: at 1-year revisit
Patients being current smokers at their initial care who successfully quit smoking.
at 1-year revisit
Goal: physical activity
Tidsramme: at 1-year revisit
reported >30 minutes of physical activity ≥5 times a week
at 1-year revisit
Goal: statin treatment
Tidsramme: at 1-year revisit
on statin treatment 1 year after the index MI
at 1-year revisit
Goal: Renin-angiotensin-aldosteron system (RAAS)-inhibition
Tidsramme: 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.
at 1-year revisit
Goal: HbA1c goal
Tidsramme: at 1-year revisit
Patients with diabetes with attained HbA1c treatment target
at 1-year revisit
SPA: cardiac rehabilitation program
Tidsramme: during 1st year after initial care
participation in structured program after the index MI
during 1st year after initial care
SPA: diet course
Tidsramme: during 1st year after initial care
participation in course after the index MI
during 1st year after initial care
SPA: statin intensity increase
Tidsramme: 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))
2 months or 1 year after initial care
SPA: high intensity statins
Tidsramme: at 1-year revisit
on high intensity statin treatment (Rosuvastatin 20-40 mg or Atorvastatin 40-80 mg)
at 1-year revisit
SPA: LDL-C reduction
Tidsramme: 2 months and 1 year after initial care
LDL-C reduction between routine revisits
2 months and 1 year after initial care
SPA: lipid monitoring
Tidsramme: 2 months or 1 year after initial care
Blood lipid panel measured
2 months or 1 year after initial care
SPA: type of follow-up
Tidsramme: 2 month revisit
decided follow-up by office revisit or by phone
2 month revisit
SPA: reperfusion
Tidsramme: initial care
type of reperfusion treatment chosen in STEMI and NSTEMI
initial care
SPA: revascularized
Tidsramme: initial care
achieved complete revascularization in STEMI and NSTEMI
initial care
SPA: staged procedure
Tidsramme: initial care
Decision on continued invasive procedures at a later stage
initial care
SPA: smoking cessation counseling
Tidsramme: 2 months or 1 year after initial care
received through cessation program or counseling
2 months or 1 year after initial care
SPA: HbA1c monitoring
Tidsramme: 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
during initial care, at 2 months and 1 year after initial care
SPA: Anti-stress program
Tidsramme: 1 year after initial care
Patients reporting anxiety or sadness participating in anti-stress program
1 year after initial care
SPA: counter-metabolic syndrome actions
Tidsramme: 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
2 months or 1 year after initial care

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Karolinska Institutet

Etterforskere

  • Hovedetterforsker: Per O Svensson, MD PhD, Department of Clinical Science and Education, Söderjukhuset

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2006

Primær fullføring (Faktiske)

31. desember 2018

Datoer for studieregistrering

Først innsendt

12. desember 2019

Først innsendt som oppfylte QC-kriteriene

12. desember 2019

Først lagt ut (Faktiske)

16. desember 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. februar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. februar 2020

Sist bekreftet

1. februar 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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Sponsorer og samarbeidspartnere

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Forhold

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Legemiddelintervensjoner

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Steder

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