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Depression and Anxiety in the Aetiology and Prognosis of Specific Cardiovascular Disease Syndromes: a CALIBER Study

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ClinicalTrials.gov Identifier: NCT01240798
Recruitment Status : Unknown
Verified January 2010 by University College, London.
Recruitment status was:  Active, not recruiting
First Posted : November 15, 2010
Last Update Posted : November 23, 2010
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease
Depression Anxiety Coronary Disease Cardiovascular Disease

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Study Design

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Depression and Anxiety in the Aetiology and Prognosis of Specific Cardiovascular Disease Syndromes: a CALIBER Study Using Linked GPRD-MINAP-HES Data
Study Start Date : January 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Depression, anxiety


Outcome Measures

Primary Outcome Measures :
  1. Chronic stable angina [ Time Frame: 1 year from date of first presentation ]

Secondary Outcome Measures :
  1. Coronary artery bypass graft (CABG) [ Time Frame: 1 year from date of first presentation ]
  2. Acute, non-fatal ST Elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina [ Time Frame: 1 year from date of first presentation ]
  3. Death (including sudden death) [ Time Frame: 1 year from date of first presentation ]
  4. Stroke [ Time Frame: 1 year from first presentation ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include all adults (18+) in GPRD registered in up-to-standard practices with at least 1 year of up to standard follow up. Analyses will focus on the ~200 practices which have consented to linkage with HES and MINAP. Essentially we will define an aetiological cohort - whole population - free of any coronary syndrome at start of follow up. Patients within this cohort are followed for the aetiologic endpoint of a first specific coronary syndrome (see below). This aetiologic endpoint is the prognostic start-point; such patients will then be followed for subsequent specific coronary syndromes and death. We will focus analyses on patients with at least a year follow up data before and their endpoint. As in a conventional cohort study we will define according to exposure history.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240798


Locations
United Kingdom
Clinical Epidemiology Group, University College London
London, United Kingdom, WC1E 6BT
Sponsors and Collaborators
University College, London
London School of Hygiene and Tropical Medicine
Brighton & Sussex Medical School
Investigators
Principal Investigator: Harry Hemingway, FRCP University College, London
Study Director: Harry Hemingway, FRCP University College, London
More Information

Responsible Party: Professor Harry Hemingway, University College London
ClinicalTrials.gov Identifier: NCT01240798     History of Changes
Other Study ID Numbers: CALIBER 09-10
Wellcome Trust 086091/Z/08/Z ( Other Grant/Funding Number: Wellcome Trust grant )
First Posted: November 15, 2010    Key Record Dates
Last Update Posted: November 23, 2010
Last Verified: January 2010

Keywords provided by University College, London:
Depression
Anxiety
Coronary disease

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Behavioral Symptoms
Mood Disorders
Mental Disorders
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases