- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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)
Studieoversikt
Status
Forhold
Detaljert 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).
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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London, Storbritannia, WC1E 7HT
- London School of Hygiene & Tropical Medicine
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London, Storbritannia, NW3 2PF
- University College London (UCL)
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Harry Hemingway, FRCP, UCL
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CALIBER 09-08
- Ref G0800689, no. 87420 (Annet stipend/finansieringsnummer: Medical Research Council)
- Ref 086091/Z/08/Z (Annet stipend/finansieringsnummer: Wellcome grant)
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