Survival After First Myocardial Infarction in Patients With and Without Chronic Obstructive Pulmonary Disease

Sponsor

London School of Hygiene and Tropical Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01335672

Collaborator

British Medical Research Council (Other), University College, London (Other)

2,100,000

Enrollment

Location

Duration (Months)

46622

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

An estimated three million people are affected by chronic obstructive pulmonary disease (COPD) in the UK, giving it a prevalence of 1.5% of the population in 2007/08. COPD accounts for approximately 30,000 deaths each year in the UK and is an important co-morbidity in those dying from other smoking related diseases, most commonly ischaemic heart disease and lung cancer. The National COPD audit showed a very high level of co-morbidity, the association with cardiovascular disease being particularly strong with 51% of patients with cardiovascular disease having been admitted for COPD within the preceding 24 months. Patients with COPD are at increased risk of myocardial infarction compared to the general population. Although this increase in cardiovascular risk exists, it is not clear is whether survival after myocardial infarction is different in patients with and without COPD and what factors contribute to this survival difference. Differences in survival may arise due to differences in prescribing certain drugs such as beta-blockers, differences in prevalence of risk factors (e.g. current smoking status) or increased COPD events such as exacerbations which themselves are associated with increased mortality.

The investigators primary aim is to investigate whether survival after first myocardial infarction is shorter in patients with COPD than those without COPD and to establish reasons for these differences in survival.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction Chronic Obstructive Pulmonary Disease

Detailed Description

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 (GPRD) 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).

Objectives:

To investigate survival differences after first myocardial infarction in patients with and without COPD.
To investigate if these survival differences exist due to a) differences in prevalence of risk factors (e.g. smoking) b) differences in management after myocardial infarction (e.g. uptake of cardiac rehabilitation, prescription of beta-blockers) and c) COPD related events (e.g. exacerbations).

Study Design

Study Type:

Observational

Actual Enrollment :

2100000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Survival After First Myocardial Infarction in Patients With and Without Chronic Obstructive Pulmonary Disease

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
GPRD patients All patients included in "up to standard" GPRD practices that agreed to the linkage with the MINAP database are included in this cohort.

Outcome Measures

Primary Outcome Measures

Death after a first ST elevation or non ST elevation MI [Average time frame: patients in the GPRD are followed from registration until they experience the outcome, leave the practice, die, or 31st December 2009, whichever occurs first]
The primary outcome is death after a first ST elevation or non ST elevation MI. Death information will be based on data from one or more of the following: ONS death certificates; Hospital Episode Statistics; MINAP data; GPRD data.

Secondary Outcome Measures

Number of patients with and without COPD prescribed a beta blocker after a MI [Average time frame: patients in the GPRD are followed from registration until they experience the outcome, leave the practice, die, or 31st December 2009, whichever occurs first]
Survival differences will be investigated with respect to a) differences in prevalence of risk factors (e.g. smoking) b) differences in management after myocardial infarction (e.g. uptake of cardiac rehabilitation, prescription of beta-blockers) and c) COPD related events (e.g. exacerbations).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients in GPRD practices which are deemed "up to standard" by GPRD criteria will be included if their practice agreed to be linked to the MINAP dataset.
Age over 18.

Exclusion Criteria:

Patients will be excluded after experiencing their first MI.
Patients will be excluded if they do not fulfil one of the inclusion criteria.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	London School of Hygiene and Tropical Medicine	London		United Kingdom	WC1E 7HT

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine
British Medical Research Council
University College, London

Investigators

Principal Investigator: Jennifer K Quint, MRCP PhD, London School of Hygiene and Tropical Medicine
Study Director: Harry Hemingway, FRCP, University College, London