- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01106196
The Role of Influenza as a Trigger for Acute Myocardial Infarction: a CALIBER Study
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)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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).
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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London, Det Forenede Kongerige, WC1E 7HT
- London School of Hygiene & Tropical Medicine
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London, Det Forenede Kongerige, NW3 2PF
- University College London (UCL)
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Incidence ratio for acute MI
Tidsramme: 28 days
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Incidence ratio for MI occurring in time periods after presentation to primary care with an acute respiratory illness compared to baseline time periods
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28 days
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Harry Hemingway, FRCP, UCL
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CALIBER 09-08
- Ref G0800689, no. 87420 (Andet bevillings-/finansieringsnummer: Medical Research Council)
- Ref 086091/Z/08/Z (Andet bevillings-/finansieringsnummer: Wellcome grant)
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