Cardiovascular Medication Use Before First Myocardial Infarction
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Purpose
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.
| Condition |
|---|
|
Myocardial Infarction |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| 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 |
- All cause mortality [ Time Frame: Up to seven years ] [ Designated as safety issue: No ]All cause mortality, using Office for National Statistics (ONS) mortality statistics
- Re-infarction [ Time Frame: One year after initial myocardial infarction ] [ Designated as safety issue: No ]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.
- Myocardial infarciton (MI) type [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]Diagnosed ST-elevation MI or non ST-elevation myocardial infarction
- Infarct size [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]Infarct size, as measured by levels of peak troponin in hospital, as recorded in the MINAP data source.
| Enrollment: | 17000 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| MI patients |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
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 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.
Exclusion Criteria:
Patients will be excluded if they do not fulfil one of the inclusion criteria.
Contacts and Locations| United Kingdom | |
| London School of Hygiene and Tropical Medicine | |
| London, United Kingdom, WC1E 7HT | |
| Principal Investigator: | Emily Herrett, MSc | London School of Hygiene and Tropical Medicine |
| Study Director: | Harry Hemingway, FRCP | University College, London |
More Information
Additional Information:
No publications provided
| Responsible Party: | Emily Herrett, Principle Investigator, London School of Hygiene and Tropical Medicine |
| ClinicalTrials.gov Identifier: | NCT01692795 History of Changes |
| Other Study ID Numbers: | CALIBER_EH3, 086091/Z/08/Z |
| Study First Received: | September 21, 2012 |
| Last Updated: | September 25, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by London School of Hygiene and Tropical Medicine:
|
Myocardial infarction Antiplatelets Lipid lowering agents ACE inhibitors |
Angiotensin Receptor Blockers Beta blockers Blood pressure lowering drugs |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Antihypertensive Agents Cardiovascular Agents Angiotensin Receptor Antagonists Therapeutic Uses Pharmacologic Actions Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013