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Cardiovascular Medication Use Before First Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01692795
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : October 2, 2015
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
Emily Herrett, London School of Hygiene and Tropical Medicine

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
Myocardial Infarction

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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 : September 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort
MI patients



Primary Outcome Measures :
  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 Outcome Measures :
  1. Myocardial infarciton (MI) type [ Time Frame: Measured at baseline ]
    Diagnosed ST-elevation MI or non ST-elevation myocardial infarction


Other Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692795


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

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Responsible Party: Emily Herrett, Principle Investigator, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01692795    
Other Study ID Numbers: CALIBER_EH3
086091/Z/08/Z ( Other Grant/Funding Number: Wellcome Trust )
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: October 2015
Keywords provided by Emily Herrett, 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:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases