Cardiovascular Medication Use Before First Myocardial Infarction

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692795
• Other study ID #: CALIBER_EH3
• Secondary ID: 086091/Z/08/Z
• Status: Completed
• Phase: N/A
• First received: September 21, 2012
• Last updated: October 1, 2015
• Start date: September 2009
• Est. completion date: September 2013

Study information

• Verified date: October 2015
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17000
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
United Kingdom	London School of Hygiene and Tropical Medicine	London

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infarct size	Infarct size, as measured by levels of peak troponin in hospital, as recorded in the MINAP data source.	Measured at baseline	No
Primary	All cause mortality	All cause mortality, using Office for National Statistics (ONS) mortality statistics	Up to seven years	No
Primary	Re-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	No
Secondary	Myocardial infarciton (MI) type	Diagnosed ST-elevation MI or non ST-elevation myocardial infarction	Measured at baseline	No