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OpenTrials
Completed

NCT Number: NCT01692795

Cardiovascular Medication Use Before First Myocardial Infarction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

London School of Hygiene and Tropical Medicine

London, WC1E 7HT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. All cause mortality

    Time frame: Up to seven years

    All cause mortality, using Office for National Statistics (ONS) mortality statistics

  2. 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.

Secondary outcomes

  1. Myocardial infarciton (MI) type

    Time frame: Measured at baseline

    Diagnosed ST-elevation MI or non ST-elevation myocardial infarction

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • University College, London

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 25, 2012
Registry last updated
Oct 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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