- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01944397
A CALIBER Study: Risk Factors for Stroke, Heart Failure, and Myocardial Infarction in Atrial Fibrillation
Risk Factors for the Development of Stroke, Heart Failure, and Myocardial Infarction in Patients Diagnosed With Atrial Fibrillation: a CALIBER Study
Panoramica dello studio
Stato
Descrizione dettagliata
The development of stroke in AF patients continues to be an area of substantial research focus. However, comparatively little research has investigated the extent to which HF and MI also make a substantial contribution to morbidity and mortality in this patient group, and whether there is overlap in the prognostic factors associated development of stroke, HF, and MI.
Conen et al. demonstrated that mortality risk in AF patients is partly mediated by the development of non-fatal stroke, HF, and MI. However, they did not investigate differences in the cumulative incidence of these conditions between different patient groups (e.g. men and women), or the relationship between potential prognostic factors and the development of these conditions. Sets of prognostic factors for stroke and HF in AF patients have been defined through the development of prognostic models, but these models were developed specifically for each condition so it is unclear whether these prognostic factors are associated with increased risk of a particular condition, or simply any major adverse cardiovascular event. Additionally, some potentially important prognostic factors were not evaluated in these studies (e.g. anaemia and kidney failure).
Thus we chose to conduct an exploratory study of prognostic factors for HF, MI, and stroke in patients diagnosed with AF. We selected our candidate factors from those that have previously been associated with stroke, HF, or MI (in AF patients or the general population). Identification of prognostic factors for stroke, HF, and MI in those diagnosed with AF is a first step toward understanding both the development of these conditions, and the scope for targeting preventive treatments to improve prognosis.
This study will be undertaken using linked electronic health record data for primary and secondary care from CALIBER. This data set contains a broad range of clinically relevant, clinically conducted measurements of potential prognostic factors, and also provides a very large baseline sample from which we can draw a sufficient number of incident AF cases to investigate our three endpoints.
The study has two aims. First, to determine the cumulative incidence of fatal and non-fatal heart failure (HF), myocardial infarction (MI) and stroke (ischaemic, haemorrhagic, and NOS) in patients diagnosed with atrial fibrillation (AF). Differences between clinically relevant groups (e.g. men and women) will be explored. Second, to compare the direction and magnitude of associations between prognostic factors and the development of these conditions (HF, stroke, MI) in patients with AF. The following panels of prognostic factors will be investigated: sociodemographic; anthropomorphic and haemodynamic; behavioural; co-existing conditions (cardiovascular and non-cardiovascular); blood biomarkers; secondary preventive drugs.
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).
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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London, Regno Unito, WC1E 7H
- University College London
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Patients with a coded diagnosis for atrial fibrillation in their primary or secondary care record.
- Patients in GPRD practices which are deemed "up to standard" by GPRD criteria
- Patients whose records are deemed "acceptable" by GPRD criteria and contain at least one year of data
- Patients whose age and sex, as recorded in GPRD is the same as that recorded in HES.
Exclusion Criteria:
- A diagnosis of heart failure, stroke, or myocardial infarction occurring before diagnosis of atrial fibrillation
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Atrial fibrillation
Patients with a diagnosis of atrial fibrillation recorded in primary or secondary care during the study period.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Heart failure
Lasso di tempo: Throughout follow-up (maximum 12 years)
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Throughout follow-up (maximum 12 years)
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Myocardial infarction
Lasso di tempo: Throughout follow-up (maximum 12 years)
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Throughout follow-up (maximum 12 years)
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Stroke (ischaemic, haemorrhagic, and NOS)
Lasso di tempo: Throughout follow-up (maximum 12 years)
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Throughout follow-up (maximum 12 years)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Non-cardiovascular mortality
Lasso di tempo: Throughout follow-up (maximum 12 years)
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Throughout follow-up (maximum 12 years)
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Cardiovascular mortality
Lasso di tempo: Throughout follow-up (maximum 12 years)
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Excluding heart failure, myocardial infarction, stroke
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Throughout follow-up (maximum 12 years)
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Katherine I Morley, PhD, University College, London
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Ischemia
- Processi patologici
- Necrosi
- Ischemia miocardica
- Malattie cardiache
- Malattia cardiovascolare
- Malattie vascolari
- Disturbi cerebrovascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Aritmie, cardiache
- Infarto miocardico
- Infarto
- Arresto cardiaco
- Ictus
- Fibrillazione atriale
Altri numeri di identificazione dello studio
- CALIBER-12-03-PROG-18
- RP-PG-0407-10314 (Altro numero di sovvenzione/finanziamento: Wellcome Trust)
- 086091/Z/08/Z (Altro numero di sovvenzione/finanziamento: Wellcome Trust)
- G0902393 (Altro numero di sovvenzione/finanziamento: Medical Research Council (UK))
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .