Myocardial InfarctionNCT01692795
Cardiovascular Medication Use Before First Myocardial Infarction
An observational study of Myocardial Infarction, run by London School of Hygiene and Tropical Medicine at 1 site in United Kingdom.
Trial summary
Large randomised trials have shown that cardiovascular medications prescribed to patients at high cardiovascular risk are effective in reducing the incidence of cardiovascular events. Their use is recommended in the United Kingdom and international guidelines (e.g. the National Institute of Clinical Excellence). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 17,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Sep 2013
- 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 with a first myocardial infarction who are registered at those General Practice Research Database (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 United Kingdom (UK) practices, and 98% of people in the UK are registered with a General Practitioner (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 Myocardial Ischaemic National Audit Project (MINAP), Hospital Episode Statistics (HES) and Office for National Statistics (ONS) datasets.
- Patients must have at least one year of GPRD "up to standard" registration before the date of first myocardial infarction.
- Age over 18. First myocardial infarction occurring between 1st January 2003 and 31st December 2008, as recorded in the HES data or MINAP.
Who cannot join
- 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
Official title: Cardiovascular Medication Prescriptions Before First Myocardial Infarction in Patients With and Without Previously Diagnosed Atherosclerotic Disease: an Analysis of Linked Prospectively Collected Electronic Healthcare Records
Large randomised trials have shown that cardiovascular medications prescribed to patients at high cardiovascular risk are effective in reducing the incidence of cardiovascular events. Their use is recommended in the United Kingdom and international guidelines (e.g. the National Institute of Clinical Excellence). However, these medications do not prevent cardiovascular events in all patients and there is now a body of research investigating the effects of cardiovascular medications on outcomes in myocardial infarction (MI), including clinical presentation, infarct size and post-MI mortality. However, the independent effects of cardiovascular drugs on post-MI all cause mortality are unclear, and there are limitations to many of the published studies in terms of their cardiovascular drug exposure data. This project utilizes prospectively collected data on cardiovascular drug use, and links to MI data from hospital and mortality records.
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial infarction, Antiplatelets, Lipid lowering agents, ACE inhibitors, Angiotensin Receptor Blockers, Beta blockers, Blood pressure lowering drugs
- Medical subject headings
- Myocardial Infarction
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 |
|---|---|---|
| MI patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
All cause mortality, using Office for National Statistics (ONS) mortality statistics
Measured: Up to seven years
Re-infarction
Reinfarction will be measured based on data from the General Practice Research Database (GPRD), Hospital Episode Statistics (HES), the Myocardial Ischaemia National Audit Project (MINAP) and Office for National Statistics (ONS) mortality data.
Measured: One year after initial myocardial infarction
Secondary outcomes (1)
Myocardial infarciton (MI) type
Diagnosed ST-elevation MI or non ST-elevation myocardial infarction
Measured: Measured at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startSep 2009
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 17,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Principal investigator, Emily Herrett, London School of Hygiene and Tropical Medicine
- Investigators
- Emily Herrett, MSc, Principal investigator, London School of Hygiene and Tropical MedicineHarry Hemingway, FRCP, Study director, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692795
- Sponsor's protocol ID
- CALIBER_EH3
- Other IDs
- 086091/Z/08/Z
- Status last verified
- Oct 2015
- First submitted
- 21 Sep 2012
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Medication Prescriptions Before First Myocardial Infarction in Patients With and Without Previously Diagnosed Atherosclerotic Disease: an Analysis of Linked Prospectively Collected Electronic Healthcare Records
- ClinicalTrials.gov ID
- NCT01692795
- Acronym / sponsor ID
- CALIBER_EH3
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial infarction, Antiplatelets, Lipid lowering agents, ACE inhibitors, Angiotensin Receptor Blockers, Beta blockers, Blood pressure lowering drugs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,000 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- Sep 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 25 Sep 2012 (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.
Large randomised trials have shown that cardiovascular medications prescribed to patients at high cardiovascular risk are effective in reducing the incidence of cardiovascular events. Their use is recommended in the United Kingdom and international guidelines (e.g. the National Institute of Clinical Excellence). However, these medications do not prevent cardiovascular events in all patients and there is now a body of research investigating the effects of cardiovascular medications on outcomes in myocardial infarction (MI), including clinical presentation, infarct size and post-MI mortality. However, the independent effects of cardiovascular drugs on post-MI all cause mortality are unclear, and there are limitations to many of the published studies in terms of their cardiovascular drug exposure data. This project utilizes prospectively collected data on cardiovascular drug use, and links to MI data from hospital and mortality records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MI patients | – | – |
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 with a first myocardial infarction who are registered at those General Practice Research Database (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 United Kingdom (UK) practices, and 98% of people in the UK are registered with a General Practitioner (GP). Therefore the GPRD should be a representative sample of the UK population.
Key inclusion criteria (3 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 Myocardial Ischaemic National Audit Project (MINAP), Hospital Episode Statistics (HES) and Office for National Statistics (ONS) datasets.
- Patients must have at least one year of GPRD "up to standard" registration before the date of first myocardial infarction.
- Age over 18. First myocardial infarction occurring between 1st January 2003 and 31st December 2008, as recorded in the HES data or MINAP.
Key exclusion criteria (1 listed)
- 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
All cause mortality
Time frame: Up to seven years
All cause mortality, using Office for National Statistics (ONS) mortality statistics
Re-infarction
Time frame: One year after initial myocardial infarction
Reinfarction will be measured based on data from the General Practice Research Database (GPRD), Hospital Episode Statistics (HES), the Myocardial Ischaemia National Audit Project (MINAP) and Office for National Statistics (ONS) mortality data.
1 secondary outcome
Myocardial infarciton (MI) type
Time frame: Measured at baseline
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 2 Oct 2015.
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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.
Emily Herrett, MSc 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, 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 3 inclusion and 1 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 2 Oct 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?
All cause mortality (time frame: Up to seven years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2015; AzTrials last refreshed its copy on 30 Oct 2026.