Cardiovascular Medication Use Before First Myocardial Infarction

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
Emily Herrett, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01692795
First received: September 21, 2012
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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
Myocardial Infarction

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: Up to seven years ] [ Designated as safety issue: No ]
    All cause mortality, using Office for National Statistics (ONS) mortality statistics

  • Re-infarction [ Time Frame: One year after initial myocardial infarction ] [ Designated as safety issue: No ]
    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 [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    Diagnosed ST-elevation MI or non ST-elevation myocardial infarction


Other Outcome Measures:
  • Infarct size [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    Infarct size, as measured by levels of peak troponin in hospital, as recorded in the MINAP data source.


Enrollment: 17000
Study Start Date: September 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
MI patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692795

Locations
United Kingdom
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
  More Information

No publications provided

Responsible Party: Emily Herrett, Principle Investigator, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01692795     History of Changes
Other Study ID Numbers: CALIBER_EH3, 086091/Z/08/Z
Study First Received: September 21, 2012
Last Updated: September 25, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by London School of Hygiene and Tropical Medicine:
Myocardial infarction
Antiplatelets
Lipid lowering agents
ACE inhibitors
Angiotensin Receptor Blockers
Beta blockers
Blood pressure lowering drugs

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Antihypertensive Agents
Cardiovascular Agents
Angiotensin Receptor Antagonists
Therapeutic Uses
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014