Socioeconomic Status, Secondary Prevention Activities and Recurrence After a Myocardial Infarction
2020年2月18日 更新者：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).
調査の概要
研究の種類
観察的
入学 (実際)
30191
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～76年 (大人、高齢者)
健康ボランティアの受け入れ
なし
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
|---|
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
first recurrent atherosclerotic cardiovascular disease event (rASCVD)
時間枠：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)
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Goal: physical training program
時間枠：at 1-year revisit
|
participated in organized physical training program after the initial care
|
at 1-year revisit
|
|
Goal: LDL-C goal
時間枠：at 1-year revisit
|
attained LDL-C level below treatment target
|
at 1-year revisit
|
|
Goal: Blood pressure goal
時間枠：at 1-year revisit
|
attained blood pressure levels below treatment target
|
at 1-year revisit
|
|
Goal: smoking cessation
時間枠：at 1-year revisit
|
Patients being current smokers at their initial care who successfully quit smoking.
|
at 1-year revisit
|
|
Goal: physical activity
時間枠：at 1-year revisit
|
reported >30 minutes of physical activity ≥5 times a week
|
at 1-year revisit
|
|
Goal: statin treatment
時間枠：at 1-year revisit
|
on statin treatment 1 year after the index MI
|
at 1-year revisit
|
|
Goal: Renin-angiotensin-aldosteron system (RAAS)-inhibition
時間枠：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
時間枠：at 1-year revisit
|
Patients with diabetes with attained HbA1c treatment target
|
at 1-year revisit
|
|
SPA: cardiac rehabilitation program
時間枠：during 1st year after initial care
|
participation in structured program after the index MI
|
during 1st year after initial care
|
|
SPA: diet course
時間枠：during 1st year after initial care
|
participation in course after the index MI
|
during 1st year after initial care
|
|
SPA: statin intensity increase
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：2 month revisit
|
decided follow-up by office revisit or by phone
|
2 month revisit
|
|
SPA: reperfusion
時間枠：initial care
|
type of reperfusion treatment chosen in STEMI and NSTEMI
|
initial care
|
|
SPA: revascularized
時間枠：initial care
|
achieved complete revascularization in STEMI and NSTEMI
|
initial care
|
|
SPA: staged procedure
時間枠：initial care
|
Decision on continued invasive procedures at a later stage
|
initial care
|
|
SPA: smoking cessation counseling
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Per O Svensson, MD PhD、Department of Clinical Science and Education, Söderjukhuset
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2006年1月1日
一次修了 (実際)
2018年12月31日
試験登録日
最初に提出
2019年12月12日
QC基準を満たした最初の提出物
2019年12月12日
最初の投稿 (実際)
2019年12月16日
学習記録の更新
投稿された最後の更新 (実際)
2020年2月20日
QC基準を満たした最後の更新が送信されました
2020年2月18日
最終確認日
2020年2月1日
詳しくは
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