Myocardial InfarctionNCT01335672
Survival After First Myocardial Infarction in Patients With and Without Chronic Obstructive Pulmonary Disease
An observational study of Myocardial Infarction and Chronic Obstructive Pulmonary Disease, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Chronic Obstructive Pulmonary Disease
- How many people
- 2,100,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- Patients will be excluded after experiencing their first MI.
- Patients will be excluded if they do not fulfil one of the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London School of Hygiene and Tropical Medicine
London, WC1E 7HT
About this study
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.
Read the 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).
- Keywords
- Myocardial infarction, chronic obstructive pulmonary disease, General Practice Research Database, Myocardial Ischaemia National Audit Project, CALIBER
- Medical subject headings
- Myocardial Infarction, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death after a first ST elevation or non ST elevation MI
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.
Measured: 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
Secondary outcomes (1)
Number of patients with and without COPD prescribed a beta blocker after a MI
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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,100,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- British Medical Research Council, University College, London
- Responsible party
- Principal investigator, Jennifer Quint, London School of Hygiene and Tropical Medicine
- Investigators
- Jennifer K Quint, MRCP PhD, Principal investigator, London School of Hygiene and Tropical MedicineHarry Hemingway, FRCP, Study director, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335672
- Sponsor's protocol ID
- 10-05
- Other IDs
- 086091/Z/08/Z
- Status last verified
- Apr 2015
- First submitted
- 12 Apr 2011
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Quint JK, Herrett E, Bhaskaran K, Timmis A, Hemingway H, Wedzicha JA, Smeeth L. Effect of beta blockers on mortality after myocardial infarction in adults with COPD: population based cohort study of UK electronic healthcare records. BMJ. 2013 Nov 22;347:f6650. doi: 10.1136/bmj.f6650.
PubMed 24270505
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival After First Myocardial Infarction in Patients With and Without Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01335672
- Acronym / sponsor ID
- 10-05
- Keywords
- Myocardial infarction, chronic obstructive pulmonary disease, General Practice Research Database, Myocardial Ischaemia National Audit Project, CALIBER
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,100,000 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- British Medical Research Council, University College, London
- Study start
- Mar 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients will be excluded after experiencing their first MI.
- Patients will be excluded if they do not fulfil one of the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
- Derived from this study: PubMed 24270505Quint JK, Herrett E, Bhaskaran K, Timmis A, Hemingway H, Wedzicha JA, Smeeth L. Effect of beta blockers on mortality after myocardial infarction in adults with COPD: population based cohort study of UK electronic healthcare records. BMJ. 2013 Nov 22;347:f6650. doi: 10.1136/bmj.f6650.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer K Quint, MRCP PhD principal investigator
London School of Hygiene and Tropical Medicine
Harry Hemingway, FRCP study director
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Chronic Obstructive Pulmonary Disease, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01335672, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.