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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
Brighton & Sussex Medical School
Information provided by:
University College, London
ClinicalTrials.gov Identifier:
NCT01240798
First received: November 11, 2010
Last updated: November 22, 2010
Last verified: January 2010
  Purpose

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
Depression
Anxiety
Coronary Disease
Cardiovascular Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Chronic stable angina [ Time Frame: 1 year from date of first presentation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Coronary artery bypass graft (CABG) [ Time Frame: 1 year from date of first presentation ] [ Designated as safety issue: No ]
  • Acute, non-fatal ST Elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina [ Time Frame: 1 year from date of first presentation ] [ Designated as safety issue: No ]
  • Death (including sudden death) [ Time Frame: 1 year from date of first presentation ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: 1 year from first presentation ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Depression, anxiety

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 11, 2010
Last Updated: November 22, 2010
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 23, 2014