Cardiovascular Medication Use Before First Myocardial Infarction

October 1, 2015 updated by: Emily Herrett, London School of Hygiene and Tropical Medicine

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

17000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, WC1E 7HT
        • London School of Hygiene and Tropical Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
MI patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: Up to seven years
All cause mortality, using Office for National Statistics (ONS) mortality statistics
Up to seven years
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.
One year after initial myocardial infarction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial infarciton (MI) type
Time Frame: Measured at baseline
Diagnosed ST-elevation MI or non ST-elevation myocardial infarction
Measured at baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infarct size
Time Frame: Measured at baseline
Infarct size, as measured by levels of peak troponin in hospital, as recorded in the MINAP data source.
Measured at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

September 21, 2012

First Submitted That Met QC Criteria

September 21, 2012

First Posted (ESTIMATE)

September 25, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 2, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

October 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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