Socioeconomic Status, Secondary Prevention Activities and Recurrence After a Myocardial Infarction
18 de febrero de 2020 actualizado por: 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).
Descripción general del estudio
Estado
Terminado
Tipo de estudio
De observación
Inscripción (Actual)
30191
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 76 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
N/A
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
first recurrent atherosclerotic cardiovascular disease event (rASCVD)
Periodo de tiempo: 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)
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Goal: physical training program
Periodo de tiempo: at 1-year revisit
|
participated in organized physical training program after the initial care
|
at 1-year revisit
|
|
Goal: LDL-C goal
Periodo de tiempo: at 1-year revisit
|
attained LDL-C level below treatment target
|
at 1-year revisit
|
|
Goal: Blood pressure goal
Periodo de tiempo: at 1-year revisit
|
attained blood pressure levels below treatment target
|
at 1-year revisit
|
|
Goal: smoking cessation
Periodo de tiempo: at 1-year revisit
|
Patients being current smokers at their initial care who successfully quit smoking.
|
at 1-year revisit
|
|
Goal: physical activity
Periodo de tiempo: at 1-year revisit
|
reported >30 minutes of physical activity ≥5 times a week
|
at 1-year revisit
|
|
Goal: statin treatment
Periodo de tiempo: at 1-year revisit
|
on statin treatment 1 year after the index MI
|
at 1-year revisit
|
|
Goal: Renin-angiotensin-aldosteron system (RAAS)-inhibition
Periodo de tiempo: 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
Periodo de tiempo: at 1-year revisit
|
Patients with diabetes with attained HbA1c treatment target
|
at 1-year revisit
|
|
SPA: cardiac rehabilitation program
Periodo de tiempo: during 1st year after initial care
|
participation in structured program after the index MI
|
during 1st year after initial care
|
|
SPA: diet course
Periodo de tiempo: during 1st year after initial care
|
participation in course after the index MI
|
during 1st year after initial care
|
|
SPA: statin intensity increase
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 2 month revisit
|
decided follow-up by office revisit or by phone
|
2 month revisit
|
|
SPA: reperfusion
Periodo de tiempo: initial care
|
type of reperfusion treatment chosen in STEMI and NSTEMI
|
initial care
|
|
SPA: revascularized
Periodo de tiempo: initial care
|
achieved complete revascularization in STEMI and NSTEMI
|
initial care
|
|
SPA: staged procedure
Periodo de tiempo: initial care
|
Decision on continued invasive procedures at a later stage
|
initial care
|
|
SPA: smoking cessation counseling
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Per O Svensson, MD PhD, Department of Clinical Science and Education, Söderjukhuset
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2006
Finalización primaria (Actual)
31 de diciembre de 2018
Fechas de registro del estudio
Enviado por primera vez
12 de diciembre de 2019
Primero enviado que cumplió con los criterios de control de calidad
12 de diciembre de 2019
Publicado por primera vez (Actual)
16 de diciembre de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de febrero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
18 de febrero de 2020
Última verificación
1 de febrero de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 3
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