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

December 1, 2014 updated by: Charlotte Warren-Gash, University College, London

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)

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

11208

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - London, United Kingdom, WC1E 7HT
    - London School of Hygiene & Tropical Medicine
  - London, United Kingdom, NW3 2PF
    - University College London (UCL)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with an incident myocardial infarction who also have a record of a visit to primary care with a respiratory tract infection occurring within the study period (01/01/99 - 31/12/2008)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
MI plus respiratory illness Patients with an incident myocardial infarction who also have a record of a visit to primary care with a respiratory tract infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

London School of Hygiene and Tropical Medicine

Open University

Investigators

Study Director: Harry Hemingway, FRCP, UCL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Warren-Gash C, Hayward AC, Hemingway H, Denaxas S, Thomas SL, Timmis AD, Whitaker H, Smeeth L. Influenza infection and risk of acute myocardial infarction in England and Wales: a CALIBER self-controlled case series study. J Infect Dis. 2012 Dec 1;206(11):1652-9. doi: 10.1093/infdis/jis597. Epub 2012 Oct 9.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)