Impact of subsequent major adverse cardiovascular events on mortality in a post-myocardial infarction population: a retrospective UK database analysis

Study type
Protocol
Date of Approval
Study reference ID
18_129
Lay Summary

Myocardial infarction (MI), otherwise known as a heart attack is relatively common with approximately 200,000 events every year in the UK. Of these about one-third will result in death. The risk of MI increases with age but other factors such as smoking, being overweight, high cholesterol and high blood pressure are also important. In addition, people who have survived an MI are at increased risk of having a second MI or other events such as a stroke. As such, people who have a MI are targeted with different treatments to reduce cholesterol and blood pressure. Recent data from a clinical trial has suggested that a drug called canakinumab may also reduce the risk of a second MI, stroke event or CV death. In this study, we wish to use the Clinical Practice Research Datalink to find a population with MI and to see how subsequent MIs or strokes increase their risk of death. This study will be important in helping to identify the size of the population that could potentially benefit from treatment with canakinumab.

Technical Summary

Incidence of myocardial infarction (MI) is predictive of subsequent major adverse cardiovascular event (MACE). In this study, we wish to identify patients with incident first MI events and to estimate the increased mortality risk associated with subsequent MACE events. The CPRD GOLD and linked datasets (HES admitted patient care and mortality) will be used. The study will be limited to CPRD acceptable patients, registered at an up-to-standard practice who are eligible for the CPRD linkage scheme. Patients with MI will be identified during the study period (2006-16) based or ICD-10 code within the HES admitted patient care database. Date of first diagnosis will be the index date. The baseline characteristics of the cases will be presented. A time-dependent Cox model for each outcome (all-cause mortality, MACE mortality and individual components) will be created with subsequent events defined within quarterly segments. Secondary outcomes comprise the individual components of MACE, lung cancer and infections. We also wish to describe the MI population in terms of social demography and to estimate the resource utilisation subsequent to first MI event.

Health Outcomes to be Measured

Major adverse cardiovascular events

Collaborators

Raquel Lahoz - Chief Investigator - NOVARTIS
Raquel Lahoz - Corresponding Applicant - NOVARTIS
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Joaquim Cristino - Collaborator - NOVARTIS
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences

Former Collaborators

Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences

Linkages

HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data