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Clinical Trials/NCT01804439
NCT01804439
Completed
Not Applicable

Cardiovascular Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes: a CALIBER Proposal Using Linked GPRD-MINAP-HES Data

University College, London0 sites2,240,000 target enrollmentJanuary 1997

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Diseases
Sponsor
University College, London
Enrollment
2240000
Primary Endpoint
First presentation of cardiovascular disease, as specified in description
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

Cardiovascular disease (CVD) is an important public health problem that affects millions of people worldwide. Associations between risk factors, such as smoking, dyslipidaemia or hypertension, and prevalent CVD are well documented. However, few studies have investigated associations with onset of disease. The initial manifestation of CVD, for example an episode of unstable angina, is important because it influences the prognosis, the quality of life and the management of disease. Furthermore, the extent to which social deprivation, alcohol consumption or atrial fibrillation affects presentation of CVD is poorly understood and deserves further consideration.

Most previous studies have considered CVD as a single entity. However, differences in aetiology between coronary phenotypes suggest that risk factors may not be shared across specific coronary phenotypes and their relative importance is likely to differ for each phenotype. Gaining knowledge of these differences could provide insights into the pathophysiology of specific forms of CVD and could eventually lead to modification of recommendations for patient management and disease prevention.

We propose to use the linkage of the national registry of coronary events to general practice records in the Clinical Practice Research Database (CPRD), to investigate whether demographic, behavioral, and clinico-metabolic risk factors differentially influence the onset of specific types of CVD.

Registry
clinicaltrials.gov
Start Date
January 1997
End Date
March 2010
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Harry Hemingway

Professor Harry Hemingway

University College, London

Eligibility Criteria

Inclusion Criteria

  • Aged ≥30yrs old
  • Registered in CPRD practices in England consenting to data linkage
  • ≥1 year of up-to-standard pre-study follow-up

Exclusion Criteria

  • History of any of the CVD endpoints considered before study follow-up initiation.

Outcomes

Primary Outcomes

First presentation of cardiovascular disease, as specified in description

Time Frame: Study follow-up will commence on the earliest date on which a patient fulfils the criteria for study inclusion within the period between 1st January 1997 and 25th March 2010 (maximum of 13 years after enrolment).

First occurrence of the following fatal or non-fatal cardiovascular outcomes: acute myocardial infarction, unstable angina, stable angina, ischemic stroke, hemorrhagic stroke, subarachnoid hemorrhage, transient ischemic attack, abdominal aortic aneurysm, peripheral arterial disease, sudden cardiac death, heart failure

Secondary Outcomes

  • Non CVD specific deaths(Same as for primary outcomes (maximum of 13 years after follow-up start))

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