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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
British Medical Research Council
University College, London
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01335672
First received: April 12, 2011
Last updated: April 13, 2011
Last verified: April 2011
  Purpose

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
Myocardial Infarction
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Survival After First Myocardial Infarction in Patients With and Without Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Death after a first ST elevation or non ST elevation MI [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 2100000
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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:

  1. To investigate survival differences after first myocardial infarction in patients with and without COPD.
  2. 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).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population is comprised of patients registered at those GPRD practices that agreed to the linkage with the MINAP database, and whose practices are "up to standard" according to GPRD criteria. Practices taking part in the GPRD are chosen to be representative of all UK practices, and 98% of people in the UK are registered with a GP. Therefore the GPRD should be a representative sample of the UK population

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335672

Locations
United Kingdom
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
  More Information

No publications provided by London School of Hygiene and Tropical Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jennifer Quint, MRCP PhD, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01335672     History of Changes
Other Study ID Numbers: 10-05, 086091/Z/08/Z
Study First Received: April 12, 2011
Last Updated: April 13, 2011
Health Authority: United Kingdom: CALIBER Scientific Oversight Committee

Keywords provided by London School of Hygiene and Tropical Medicine:
Myocardial infarction
chronic obstructive pulmonary disease
General Practice Research Database
Myocardial Ischaemia National Audit Project
CALIBER

Additional relevant MeSH terms:
Infarction
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Myocardial Infarction
Lung Diseases, Obstructive
Ischemia
Pathologic Processes
Necrosis
Respiratory Tract Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014