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

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ClinicalTrials.gov Identifier: NCT01106196
Recruitment Status : Completed
First Posted : April 19, 2010
Last Update Posted : December 2, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Myocardial Infarction Influenza

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 Design

Study Type : Observational
Actual Enrollment : 11208 participants
Time Perspective: Retrospective
Official 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)
Study Start Date : April 2010
Primary Completion Date : October 2012
Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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
Contacts and Locations

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): NCT01106196


Locations
United Kingdom
University College London (UCL)
London, United Kingdom, NW3 2PF
London School of Hygiene & Tropical Medicine
London, United Kingdom, WC1E 7HT
Sponsors and Collaborators
University College, London
London School of Hygiene and Tropical Medicine
Open University
Investigators
Study Director: Harry Hemingway, FRCP UCL
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charlotte Warren-Gash, Dr, University College, London
ClinicalTrials.gov Identifier: NCT01106196     History of Changes
Other Study ID Numbers: CALIBER 09-08
Ref G0800689, no. 87420 ( Other Grant/Funding Number: Medical Research Council )
Ref 086091/Z/08/Z ( Other Grant/Funding Number: Wellcome grant )
First Posted: April 19, 2010    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by Charlotte Warren-Gash, University College, London:
Influenza, Human
Influenza, Human/complications
Myocardial infarction/etiology
Cardiovascular Diseases/mortality

Additional relevant MeSH terms:
Influenza, Human
Infarction
Myocardial Infarction
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases