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Completed

NCT Number: NCT01106196

The Role of Influenza as a Trigger for Acute Myocardial Infarction: a CALIBER Study

The purpose of this study is to examine the incidence of acute myocardial infarction (MI) occurring after an influenza-like illness using linked primary care and disease registry databases.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

London School of Hygiene & Tropical Medicine, London, United Kingdom

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About this study

This study will measure the incidence ratio for MI occurring in time periods after presentation with an acute respiratory illness compared to baseline time periods using the self-controlled case series method, with reference to the timing of the influenza season (defined by national virological and clinical surveillance data). It will also validate accuracy and completeness of information on MI in the GPRD using linked anonymised data from both MINAP and Hospital Episode Statistics.

This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants must be registered with a GPRD 'up to standard' practice during the study period 01/01/1999-31/12/2008
  • They must have a record of an incident myocardial infarction (defined by a Read codelist submitted to and agreed by GPRD) that occurs both within their registration and the study period
  • They must have at least 6 months between their registration date and the date of the incident MI
  • They must have accessed primary care on at least one occasion for a respiratory illness during the study period

Exclusion criteria

  • Not fulfilling above criteria

Treatment and study plan

Primary outcomes

  1. Incidence ratio for acute MI

    Time frame: 28 days

    Incidence ratio for MI occurring in time periods after presentation to primary care with an acute respiratory illness compared to baseline time periods

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • London School of Hygiene and Tropical Medicine
  • Open University

Registry information

Official study title

The Role of Influenza as a Trigger for Acute Myocardial Infarction: a Self-controlled Case Series Analysis of Linked Data From the Myocardial Ischaemia National Audit Project (MINAP) and the General Practice Research Database (GPRD)

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 19, 2010
Registry last updated
Dec 2, 2014

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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