- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Detailní popis
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).
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
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London, Spojené království, WC1E 7H
- University College London
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Heart failure
Časové okno: Throughout follow-up (maximum 12 years)
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Throughout follow-up (maximum 12 years)
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Myocardial infarction
Časové okno: 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)
Časové okno: Throughout follow-up (maximum 12 years)
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Throughout follow-up (maximum 12 years)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Non-cardiovascular mortality
Časové okno: Throughout follow-up (maximum 12 years)
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Throughout follow-up (maximum 12 years)
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Cardiovascular mortality
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Katherine I Morley, PhD, University College, London
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Ischemie
- Patologické procesy
- Nekróza
- Ischémie myokardu
- Srdeční choroba
- Kardiovaskulární choroby
- Cévní onemocnění
- Cerebrovaskulární poruchy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Arytmie, srdeční
- Infarkt myokardu
- Infarkt
- Srdeční selhání
- Mrtvice
- Fibrilace síní
Další identifikační čísla studie
- CALIBER-12-03-PROG-18
- RP-PG-0407-10314 (Jiné číslo grantu/financování: Wellcome Trust)
- 086091/Z/08/Z (Jiné číslo grantu/financování: Wellcome Trust)
- G0902393 (Jiné číslo grantu/financování: Medical Research Council (UK))
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