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临床试验/NCT01944397
NCT01944397Unknown不适用

Risk Factors for the Development of Stroke, Heart Failure, and Myocardial Infarction in Patients Diagnosed With Atrial Fibrillation: a CALIBER Study

University College, London1 个研究点 分布在 1 个国家目标入组 125,000 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
125,000
试验地点
1
主要终点
Heart failure

研究概览

简要总结

We aim to investigate the prognosis of patients diagnosed with AF, particularly in relation to the development of subsequent stroke, heart failure, and myocardial infarction. We will explore the relationship between these outcomes and a range of risk factors.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • A diagnosis of heart failure, stroke, or myocardial infarction occurring before diagnosis of atrial fibrillation

结局指标

主要结局

Heart failure

时间窗: Throughout follow-up (maximum 12 years)

Stroke (ischaemic, haemorrhagic, and NOS)

时间窗: Throughout follow-up (maximum 12 years)

Myocardial infarction

时间窗: Throughout follow-up (maximum 12 years)

次要结局

  • Non-cardiovascular mortality(Throughout follow-up (maximum 12 years))
  • Cardiovascular mortality(Throughout follow-up (maximum 12 years))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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