Big Data to Assess the Healthcare and Health Outcomes Burden of Acute Coronary Syndromes Complicated With Heart Failure

Heart Failure Clinical Trial

— BEAT-HF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06255418
• Other study ID #: PR251/22
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2024
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7860560
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Heart Decompensation
• Heart Failure
• Infarction
• Myocardial Infarction
• Myocardial Infarction, Acute
• Syndrome

Locations

Country	Name	City	State
Spain	University Hospital Bellvitge	L'Hospitalet de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge	Institut d'Investigació Biomèdica de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline characteristics	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.	Between January 1st, 2012 and 31st, December 2021 (study period).
Primary	Incidence of heart failure after acute coronary syndrome	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	Between January 1st, 2012 and 31st, December 2021 (study period).
Secondary	Clinical endpoints	All-cause death; Left ventricular assist device (LVAD) implant; Heart transplant (HTx); Need of cardiovascular (CV) procedures: coronary artery bypass grafting (CABG), percutaneous revascularization, implantable cardioverter-defibrillator (ICD) implant; Recurrent acute coronary syndromes (ACS); Stroke; Cardiovascular (CV)-related hospitalization; Heart Failure (HF) hospitalization; 5-point MACE: death, incident HF, new ACS, stroke, need of cardiovascular intervention (CABG or percutaneous revascularization); Relevant cardiovascular medication by therapeutic class during the first year after the event.	Between January 1st, 2012 and 31st, December 2021 (study period).
Secondary	Healthcare resource use endpoints	Emergency Department (ED) visits; Daycare visits; Outpatient specialist contacts; Total primary care contacts; Primary care nurse contacts; Primary care physician contacts; Use of skilled nurse facility; Unplanned HF admission; Unplanned CV readmission; Unplanned clinically related readmission (includes CV readmissions, admissions related to pre-existing chronic non-CV conditions and complications attributable to the index hospitalization); Unplanned all-cause hospitalization; Length of hospitalization (days per admission); Healthcare expenditure: global and stratified according to specific concepts and activities; Drug costs	Between January 1st, 2012 and 31st, December 2021 (study period).