NCT01106196

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

2.5 years

First QC Date

April 16, 2010

Last Update Submit

December 1, 2014

Conditions

Keywords

Influenza, HumanInfluenza, Human/complicationsMyocardial infarction/etiologyCardiovascular Diseases/mortality

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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

You may not qualify if:

  • Not fulfilling above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University College London (UCL)

London, London, NW3 2PF, United Kingdom

Location

London School of Hygiene & Tropical Medicine

London, London, WC1E 7HT, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Myocardial InfarctionInfluenza, HumanCardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Harry Hemingway, FRCP

    UCL

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 16, 2010

First Posted

April 19, 2010

Study Start

April 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations