Overview

This trial is active, not recruiting.

Conditions heart failure, myocardial infarction
Sponsor University College, London
Collaborator UMC Utrecht
Start date March 2015
End date December 2015
Trial size 55000 participants
Trial identifier NCT02384213, 14_198R

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective

Primary Outcomes

Measure
Heart failure
time frame: Throughout follow-up (maximum 12 years)

Secondary Outcomes

Measure
Non-cardiovascular mortality
time frame: Throughout follow-up (maximum 12 years)
Cardiovascular mortality
time frame: Throughout follow-up (maximum 12 years)
Myocardial infarction
time frame: Throughout follow-up (maximum 12 years)

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Incidence of and Prognostic Factors Associated With Heart Failure Following Myocardial Infarction (iHF): a CALIBER Study
Principal investigator Folkert W. Asselbergs, MD, PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by University College, London.