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

NCT ID: NCT01106196

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Myocardial Infarction Influenza

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

Open University

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Charlotte Warren-Gash

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harry Hemingway, FRCP

Role: STUDY_DIRECTOR

UCL

Locations

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University College London (UCL)

London, London, United Kingdom

Site Status

London School of Hygiene & Tropical Medicine

London, London, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 23048170 (View on PubMed)

Other Identifiers

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Ref G0800689, no. 87420

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Ref 086091/Z/08/Z

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CALIBER 09-08

Identifier Type: -

Identifier Source: org_study_id