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

NCT06255418 | Completed

• 1 other identifier: PR251/22
• Study Type: observational
• Target: 7,860,560
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 Outcomes (2)

• Clinical endpoints

  Between January 1st, 2012 and 31st, December 2021 (study period).

• Healthcare resource use endpoints

  Between January 1st, 2012 and 31st, December 2021 (study period).

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Death before discharge from index event.

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead
• Institut d'Investigació Biomèdica de Bellvitge: collaborator

Study Sites (1)

University Hospital Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

MeSH Terms

Conditions

Heart Failure; Acute Coronary Syndrome; Myocardial Infarction

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Innovation, Research and Universities of the South-Metropolitan Healthcare Area

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 13, 2024
• Study Start: January 1, 2012
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

ES (1)