Incidence of and Prognostic Factors Associated With Heart Failure Following Myocardial Infarction: a CALIBER Study

NCT ID: NCT02384213

Last Updated: 2015-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 55000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-12-31

Brief Summary

The main objectives of this study are: i) to investigate the incidence and prevalence of fatal and non-fatal heart failure (HF) following myocardial infarction (MI) and its evolution over time in men and in women; ii) to identify prognostic factors for developing HF in patients who had an MI.

Detailed Description

Heart failure (HF) is a major medical problem in the western world. Heart failure is associated with a substantial morbidity and mortality and contributes to a significant extent to economic loss for healthcare systems. An increased prevalence of HF is expected as survival is increasing after an ischaemic event due to primary percutaneous coronary intervention (PCI) and due to demographic changes (ageing population). At this moment, no contemporary data of large scale electronic health records cohorts have been reported regarding the incidence of HF following myocardial infarction (MI). The aim of this research is to investigate the incidence of HF following MI across different time periods and search for predictors of HF following MI to identify high-risk patients. Using CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) data, patients with HF following MI will be identified and the incidence of HF after MI will be described. Prognostic factors associated with the occurrence of HF in patients having experienced a MI will be studied. This is important for future observational research, clinical trials, measuring health outcomes and guideline development.

The study has two aims. First to describe the 'real-world' incidence of HF following MI. Differences between clinically relevant groups (e.g. men and women, and patients with or without - ST-elevation MI,) will be examined. Second, to identify prognostic factors for developing HF in patients who had an MI. The following panels of prognostic factors will be investigated: sociodemographic; anthropomorphic and haemodynamic; behavioural; co-existing conditions (cardiovascular and non-cardiovascular); blood biomarkers; prescribed secondary preventive medication.

This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (CPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Conditions

Heart Failure; Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients with a coded diagnosis for myocardial infarction in their primary or secondary care record.
• Patients in CPRD practices which are deemed "up to standard" for more than 1 year by CPRD criteria.
• Patients with at least one year of follow-up in the CPRD practice CPRD.

Exclusion Criteria

• A past medical history of heart failure before index MI.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UMC Utrecht

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harry Hemingway, FRCP

Role: STUDY_DIRECTOR

University College, London

Folkert W. Asselbergs, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University College, London

Locations

Farr Institute, University College London

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

14_198R

Identifier Type: -

Identifier Source: org_study_id