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
NCT number | NCT04199663 |
Other study ID # | 3 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2006 |
Verified date | February 2020 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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).
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
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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