Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes

Completed

• Conditions: Heart Diseases; Cardiovascular Diseases; Acute Myocardial Infarction; Unstable Angina; Chronic Stable Angina; Ischemic Stroke; Cerebrovascular Accident; Subarachnoid Hemorrhage; Transient Ischemic Attack; Abdominal Aortic Aneurysm

• Registration Number: NCT01804439
• Lead Sponsor: University College, London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-01
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Study First Submitted: 2013-01-08
• Status Verified: 2013-03
• Study First Submitted QC: 2013-03-03
• Last Update Submitted: 2013-03-03
• Study First Posted: 2013-03-05
• Last Update Posted: 2013-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2240000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First presentation of cardiovascular disease, as specified in description	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 Outcome Measures

Name	Time	Method
Non CVD specific deaths	Same as for primary outcomes (maximum of 13 years after follow-up start)	Death from non CVD, that is, excluding deaths related to the primary endpoints.