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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
Open University
Information provided by:
University College, London
ClinicalTrials.gov Identifier:
NCT01106196
First received: April 16, 2010
Last updated: April 23, 2010
Last verified: April 2010
  Purpose

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
Myocardial Infarction
Influenza

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Incidence ratio for acute MI [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Incidence ratio for MI occurring in time periods after presentation to primary care with an acute respiratory illness compared to baseline time periods


Estimated Enrollment: 20000
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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).

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University College, London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Charlotte Warren-Gash, University College London (UCL)
ClinicalTrials.gov Identifier: NCT01106196     History of Changes
Other Study ID Numbers: CALIBER 09-08, Ref G0800689, no. 87420, Ref 086091/Z/08/Z
Study First Received: April 16, 2010
Last Updated: April 23, 2010
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on April 23, 2014