跳至主要内容
临床试验/NCT01240798
NCT01240798Unknown不适用

Depression and Anxiety in the Aetiology and Prognosis of Specific Cardiovascular Disease Syndromes: a CALIBER Study Using Linked GPRD-MINAP-HES Data

University College, London1 个研究点 分布在 1 个国家开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
试验地点
1
主要终点
Chronic stable angina

研究概览

简要总结

People report feeling sad and low (depression) or worried (anxiety) appear more likely to subsequently suffer a heart attack, or angina. However it is not known whether depression or anxiety actually causes heart disease. If these mental health problems and heart disease were cause and effect this has important implications for world health. Previous research on this topic has had several limitations. First, most studies have studied heart disease as if it were one thing. There is a need for studies which distinguish different types of heart disease (e.g. different types of heart attack, angina) which may be linked to mental health problems in different ways. Second, it is not clear whether symptoms of heart disease come before the depression or anxiety or the other way round? Much of the available research cannot look at this in detail because they rely on data from occasional snapshots of study populations rather than a continuous record. The investigators propose to use the linkage of the national registry of coronary events to general practice records in the GPRD, which will allow us to address these limitations. The investigators research will help us understand better whether mental health problems cause the onset of different types of coronary disease.

详细描述

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).

Overall aim

To elucidate the role of depression and anxiety in the aetiology and prognosis of specific acute and chronic coronary disease phenotypes.

Background

Coronary disease and depression are major causes of mortality and morbidity globally and so the public health impact of a causal association between the two is profound1. But our meta-analysis of 22 aetiologic cohort studies (4016 events) the presence of depression was associated with a 70% increased risk of CHD events. This systematic review, and others, identified several limitations of existing research, including a) clinical phenotype resolution: broad aggregates of CHD, rather than specific coronary phenotypes, b) small size, with insufficient event numbers to compare risks in women and men, c) temporal resolution: Single time point of exposure to depression (usually prevalent); unclear temporal relation between the onset of symptoms of depression and the onset of symptoms associated with coronary disease and lack of studies assessing whether exposure to depression prior to the onset of any symptomatic coronary disease influences the prognosis (future progression) of coronary disease once established, d) incomplete and inconsistent assessment of potential confounders or mediators: unclear role of social deprivation, smoking, alcohol and other behaviours which may confound the association; unclear role of detection, treatment and control of cardiovascular risk among patients with depression and lack of consideration of co-existing psychiatric morbidities.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged >18 years
  • Patient in a GPRD registered practice that has consented to the linkage process
  • Patients are free of any coronary syndrome at the start of follow-up

排除标准

  • Less than 1 year of follow-up before their end-point

结局指标

主要结局

Chronic stable angina

时间窗: 1 year from date of first presentation

次要结局

  • Coronary artery bypass graft (CABG)(1 year from date of first presentation)
  • Acute, non-fatal ST Elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina(1 year from date of first presentation)
  • Death (including sudden death)(1 year from date of first presentation)
  • Stroke(1 year from first presentation)

研究者

申办方类型
Other

研究点 (1)

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