Cardiovascular Medication Use Before First Myocardial Infarction

Sponsor

London School of Hygiene and Tropical Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01692795

Collaborator

University College, London (Other)

17,000

Enrollment

Location

Duration (Months)

354.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction

Study Design

Study Type:

Observational

Actual Enrollment :

17000 participants

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
MI patients

Outcome Measures

Primary Outcome Measures

All cause mortality [Up to seven years]
All cause mortality, using Office for National Statistics (ONS) mortality statistics
Re-infarction [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.

Secondary Outcome Measures

Myocardial infarciton (MI) type [Measured at baseline]
Diagnosed ST-elevation MI or non ST-elevation myocardial infarction

Other Outcome Measures

Infarct size [Measured at baseline]
Infarct size, as measured by levels of peak troponin in hospital, as recorded in the MINAP data source.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	London School of Hygiene and Tropical Medicine	London		United Kingdom	WC1E 7HT

Sponsors and Collaborators

London School of Hygiene and Tropical Medicine
University College, London

Investigators

Principal Investigator: Emily Herrett, MSc, London School of Hygiene and Tropical Medicine
Study Director: Harry Hemingway, FRCP, University College, London