NCT04199663

Brief 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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,191

participants targeted

Target at P75+ for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 16, 2019

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

13 years

First QC Date

December 12, 2019

Last Update Submit

February 18, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Other Outcomes (22)

  • Goal: physical training program

    at 1-year revisit

  • Goal: LDL-C goal

    at 1-year revisit

  • Goal: Blood pressure goal

    at 1-year revisit

  • +19 more other outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 76 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial InfarctionCardiovascular DiseasesStroke

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Per O Svensson, MD PhD

    Department of Clinical Science and Education, Söderjukhuset

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
88 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 12, 2019

First Posted

December 16, 2019

Study Start

January 1, 2006

Primary Completion

December 31, 2018

Last Updated

February 20, 2020

Record last verified: 2020-02