The Role of Influenza as a Trigger for Acute Myocardial Infarction: a CALIBER Study
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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) |
- 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 |
|---|
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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
|
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 |
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)
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| United Kingdom | |
| University College London (UCL) | |
| London, United Kingdom, NW3 2PF | |
| London School of Hygiene & Tropical Medicine | |
| London, United Kingdom, WC1E 7HT | |
| Study Director: | Harry Hemingway, FRCP | UCL |
More Information
Additional 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 May 22, 2013