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

Influenza Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106196
• Other study ID #: CALIBER 09-08
• Secondary ID: Ref G0800689, no
• Status: Completed
• Phase: N/A
• First received: April 16, 2010
• Last updated: December 1, 2014
• Start date: April 2010
• Est. completion date: October 2012

Study information

• Verified date: December 2014
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11208
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Infarction
• Influenza
• Influenza, Human
• Myocardial Infarction

Locations

Country	Name	City	State
United Kingdom	London School of Hygiene & Tropical Medicine	London
United Kingdom	University College London (UCL)	London

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	London School of Hygiene and Tropical Medicine, Open University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence ratio for acute MI	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	No