- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01240798
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
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Contacts and Locations
Study Locations
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London, United Kingdom, WC1E 6BT
- Clinical Epidemiology Group, University College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Depression, anxiety
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Chronic stable angina
Time Frame: 1 year from date of first presentation
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1 year from date of first presentation
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Coronary artery bypass graft (CABG)
Time Frame: 1 year from date of first presentation
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1 year from date of first presentation
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Acute, non-fatal ST Elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina
Time Frame: 1 year from date of first presentation
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1 year from date of first presentation
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Death (including sudden death)
Time Frame: 1 year from date of first presentation
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1 year from date of first presentation
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Stroke
Time Frame: 1 year from first presentation
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1 year from first presentation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Harry Hemingway, FRCP, University College, London
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CALIBER 09-10
- Wellcome Trust 086091/Z/08/Z (Other Grant/Funding Number: Wellcome Trust grant)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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