Clinical trial NCT01692795: Cardiovascular Medication Use Before First Myocardial Infarction
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: Myocardial infarction
Antiplatelets
Lipid lowering agents
ACE inhibitors
Angiotensin Receptor Blockers
Beta blockers
Blood pressure lowering drugs
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: University College, London
First posted: 2012-09-25
Enrollment: 17000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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). 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.


Eligibility 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 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.

Primary outcomes:
measure: All cause mortality
timeFrame: Up to seven years
measure: Re-infarction
timeFrame: One year after initial myocardial infarction
Secondary outcomes:
measure: Myocardial infarciton (MI) type
timeFrame: Measured at baseline
Other outcomes:
measure: Infarct size
timeFrame: Measured at baseline
Locations:
city: London
country: United Kingdom
facility: London School of Hygiene and Tropical Medicine
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Emily Herrett, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University College, London
name: Harry Hemingway, FRCP
role: STUDY_DIRECTOR
References: