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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04199663
Other study ID # 3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2006

Study information

Verified date February 2020
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
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. completion date
Est. primary completion date December 31, 2018
Accepts healthy volunteers
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

Study Design


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)
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