Depression and Anxiety in the Aetiology and Prognosis of Specific Cardiovascular Disease Syndromes: a CALIBER Study
Depression and Anxiety in the Aetiology and Prognosis of Specific Cardiovascular Disease Syndromes: a CALIBER Study Using Linked GPRD-MINAP-HES Data
調査の概要
詳細な説明
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.
Study design
Observational study, using cohort and case series analyses in initially healthy populations, and among patients with specific manifestations of coronary disease.
Sample size calculations
We have ample statistical power for our main hypotheses. For example we will estimate a relative risk for the effect of depression (vs not) on STEMI, and compare this with the relative risk for the effect of depression vs not on non-STEMI. Assuming depression exposure prevalence of 10%, 500 linked cases of each type and alpha of 0.01, we will be able to distinguish a relative risk of, say 1.7.
Data analysis Our overall analytic approach involves the distinction between different coronary disease phenotypes which form the endpoints of aetiologic, and the start-points of prognostic, analyses and between different temporal patterns of evolution of risk. Furthermore we will consider the separate, and joint, effects of depression and anxiety, distinguishing between a solitary measure and the cumulative impact of serial measures, on the specific coronary disease phenotypes.
A structured Statistical Analytic Protocol detailing how we will analyse the data and to what extent analytic choices are pre-specified, can be made available on request.
Expected value of results
This provides an opportunity to investigate large scale the association of depression with specific coronary syndromes comes from the linkage of GPRD to MINAP.
研究の種類
連絡先と場所
研究場所
-
-
-
London、イギリス、WC1E 6BT
- Clinical Epidemiology Group, University College London
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- Less than 1 year of follow-up before their end-point
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
---|
Depression, anxiety
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Chronic stable angina
時間枠:1 year from date of first presentation
|
1 year from date of first presentation
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
Coronary artery bypass graft (CABG)
時間枠:1 year from date of first presentation
|
1 year from date of first presentation
|
Acute, non-fatal ST Elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina
時間枠:1 year from date of first presentation
|
1 year from date of first presentation
|
Death (including sudden death)
時間枠:1 year from date of first presentation
|
1 year from date of first presentation
|
Stroke
時間枠:1 year from first presentation
|
1 year from first presentation
|
協力者と研究者
捜査官
- 主任研究者:Harry Hemingway, FRCP、University College, London
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。