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

NCT01240798 | Unknown DMC

• 2 other identifiers: CALIBER 09-10Wellcome Trust 086091/Z/08/Z
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; Coronary Disease; Cardiovascular Disease

Keywords

Depression; Anxiety; Coronary disease

Outcome Measures

Primary Outcomes (1)

• Chronic stable angina

  1 year from date of first presentation

Secondary Outcomes (4)

• 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

Study Arms (1)

Depression, anxiety

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead
• London School of Hygiene and Tropical Medicine: collaborator
• Brighton & Sussex Medical School: collaborator

Study Sites (1)

Clinical Epidemiology Group, University College London

London, WC1E 6BT, United Kingdom

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Coronary Disease; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Myocardial Ischemia; Heart Diseases; Vascular Diseases

Study Officials

• Harry Hemingway, FRCP

  University College, London

  PRINCIPAL INVESTIGATOR

• Harry Hemingway, FRCP

  University College, London

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 11, 2010
• First Posted: November 15, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: November 23, 2010

Record last verified: 2010-01

Locations

GB (1)