Clinical trial NCT06255418: Big Data to Assess the Healthcare and Health Outcomes Burden of Acute Coronary Syndromes Complicated With Heart Failure
Official title: Big Data and Real-world Evidence to Assess the Healthcare and Health Outcomes Burden of Acute Coronary Syndromes Complicated With Heart Failure: the BEAT-HF Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Acute Coronary Syndrome
Heart Decompensation
Myocardial Infarction, Acute
Keywords: heart failure
acute coronary syndrome
real-world evidence
healthcare resources consumption
long-term heart failure
big data
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
Collaborators: name: Institut d'Investigació Biomèdica de Bellvitge
First posted: 2024-02-13
Enrollment: 7860560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

Brief 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.).

Eligibility criteria: Inclusion Criteria:

* Admission with the primary diagnosis of acute coronary syndrome ( Non-ST-Elevation Myocardial Infarction -NSTEMI-, ST-Elevation Myocardial Infarction -STEMI-, Unestable Angina -UA-)

Exclusion Criteria:

* Diagnosis of heart failure (HF) in the year preceding the inclusion.
* Death before discharge from index event.

Primary outcomes:
measure: Baseline characteristics
timeFrame: Between January 1st, 2012 and 31st, December 2021 (study period).
measure: Incidence of heart failure after acute coronary syndrome
timeFrame: Between January 1st, 2012 and 31st, December 2021 (study period).
Secondary outcomes:
measure: Clinical endpoints
timeFrame: Between January 1st, 2012 and 31st, December 2021 (study period).
measure: Healthcare resource use endpoints
timeFrame: Between January 1st, 2012 and 31st, December 2021 (study period).
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: University Hospital Bellvitge
state: Barcelona
Study officials:
References: