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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04199663
• Other study ID #: 3
• Status: Completed
• Start date: January 1, 2006

Study information

• Verified date: February 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30191
• Est. primary completion date: December 31, 2018
• Gender: All
• Age group: 18 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Infarction
• Myocardial Infarction
• Neoplasm Metastasis
• Secondary Prevention
• Socioeconomic Status
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Goal: physical training program	participated in organized physical training program after the initial care	at 1-year revisit
Other	Goal: LDL-C goal	attained LDL-C level below treatment target	at 1-year revisit
Other	Goal: Blood pressure goal	attained blood pressure levels below treatment target	at 1-year revisit
Other	Goal: smoking cessation	Patients being current smokers at their initial care who successfully quit smoking.	at 1-year revisit
Other	Goal: physical activity	reported >30 minutes of physical activity =5 times a week	at 1-year revisit
Other	Goal: statin treatment	on statin treatment 1 year after the index MI	at 1-year revisit
Other	Goal: Renin-angiotensin-aldosteron system (RAAS)-inhibition	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
Other	Goal: HbA1c goal	Patients with diabetes with attained HbA1c treatment target	at 1-year revisit
Other	SPA: cardiac rehabilitation program	participation in structured program after the index MI	during 1st year after initial care
Other	SPA: diet course	participation in course after the index MI	during 1st year after initial care
Other	SPA: statin intensity increase	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
Other	SPA: high intensity statins	on high intensity statin treatment (Rosuvastatin 20-40 mg or Atorvastatin 40-80 mg)	at 1-year revisit
Other	SPA: LDL-C reduction	LDL-C reduction between routine revisits	2 months and 1 year after initial care
Other	SPA: lipid monitoring	Blood lipid panel measured	2 months or 1 year after initial care
Other	SPA: type of follow-up	decided follow-up by office revisit or by phone	2 month revisit
Other	SPA: reperfusion	type of reperfusion treatment chosen in STEMI and NSTEMI	initial care
Other	SPA: revascularized	achieved complete revascularization in STEMI and NSTEMI	initial care
Other	SPA: staged procedure	Decision on continued invasive procedures at a later stage	initial care
Other	SPA: smoking cessation counseling	received through cessation program or counseling	2 months or 1 year after initial care
Other	SPA: HbA1c monitoring	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
Other	SPA: Anti-stress program	Patients reporting anxiety or sadness participating in anti-stress program	1 year after initial care
Other	SPA: counter-metabolic syndrome actions	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
Primary	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)	from date of 1-year visit post-MI (baseline) until date of outcome, censoring or study end (2018)