Big Data to Assess the Healthcare and Health Outcomes Burden of Acute Coronary Syndromes Complicated With Heart Failure
Condition: Heart Failure; Acute Coronary Syndrome; Heart Decompensation; Myocardial Infarction, Acute
MeSH terms: Heart Failure; Myocardial Infarction; Acute Coronary Syndrome; Syndrome; Infarction
Study type: Observational

Summary: 
      The goal of this observational study is to define the incidence of heart failure (HF) after
      acute coronary syndrome (ACS). The main question it aims to answer is:

      • To define HF incidence in the medium and long-term in the context of public healthcare
      coverage ensuring universal access to early coronary revascularization after ACS and extended
      neurohormonal treatment.

      Analyses will cover the entire population of Catalonia (North-Eastern region of Spain, N =
      7.860.563 in 2020).

      Researchers will compare HF incidence rate according to relevant subgroup characteristics
      including event type, age groups or sex, inter alia.
    

Detailed description: 
      The aim of this project is to gain a better understanding, from a population perspective, of
      incident heart failure (HF) after acute coronary syndrome (ACS). The particular purpose is to
      define its incidence in the medium and long-term in the context of public healthcare coverage
      ensuring universal access to early coronary revascularization after ACS and extended
      neurohormonal treatment. To provide answer to this objective, a retrospective study were
      designed where a variety of study designs and analytic approaches will be used, aimed at
      maximizing the robustness of the results and at minimizing their sensitivity to specific
      study design assumptions. Analyses will cover the entire population of Catalonia (Spain, N =
      7.860.563 as of December 31st, 2020), a region in which the Catalan Health Service granted
      universal health coverage. The study period will be defined between January 1st, 2012, and
      December 31st, 2021 covering 10 years. Inclusion criteria will be to have been admitted and
      diagnosed with a primary diagnosis of ACS (non-ST-segment elevation myocardial infarction
      -NSTEMI-, ST-segment elevation myocardial infarction -STEMI-, unstable angina -UA-) during
      the index event and to have been discharged alive during this period. The first co-primary
      outcome is to define the baseline characteristics of the ACS population, overall and
      according to clinical interest groups including event type (STEMI, NSTEMI, UA) and other
      relevant subgroups of patients. The second co-primary outcome of the study is the incidence
      rate of HF after ACS of all patients discharged alive after an ACS in Catalonia during this
      period. Incidence rate will also be described overall and according to relevant subgroup
      characteristics including event type, clinical phenotypes surrogate of impairment in regional
      or global systolic function, age groups, sex, diabetes mellitus, HF complicating index ACS,
      recurrent ACS after index ACS, socioeconomic status, treatments, comorbidity groups and
      procedures. Other clinical outcomes will be assessed as secondary outcomes (all-cause death,
      stroke, recurrent ACS, hospitalizations, major adverse cardiac event, etc.).
    

Observational model: Ecologic or Community
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Analyses will cover the entire population of Catalonia (Spain, N = 7.860.563 as of December
        31st, 2020), a region in which the Catalan Health Service granted universal health
        coverage.
      
Keywords: heart failure; acute coronary syndrome; real-world evidence; healthcare resources consumption; long-term heart failure; big data