Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes

NCT ID: NCT01804439

Last Updated: 2013-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2240000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1997-01-31
• Study Completion Date: 2010-03-31

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.

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; Peripheral Arterial Disease; Sudden Coronary Death; Ventricular Arrhythmia; Sudden Death; Cardiac Arrest; Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CALIBER Healthy Cohort

We will report findings from the CALIBER (CArdiovascular disease research using Linked BEspoke studies and Electronic Records) collaboration where we linked primary care data (from the General Practice Research Database \[GPRD\]) to three further sources of electronic health records: the Myocardial Ischemia National Audit Project registry (MINAP),cause specific discharge data from Hospital Episodes Statistics (HES) and cause specific mortality from the Office for National Statistics (ONS).

No interventions assigned to this group

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Harry Hemingway

Professor Harry Hemingway

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Dinesh Shah A, Langenberg C, Rapsomaniki E, Denaxas S, Pujades-Rodriguez M, Gale CP, Deanfield J, Smeeth L, Timmis A, Hemingway H. Type 2 diabetes and incidence of a wide range of cardiovascular diseases: a cohort study in 1.9 million people. Lancet. 2015 Feb 26;385 Suppl 1:S86. doi: 10.1016/S0140-6736(15)60401-9.

Reference Type: DERIVED

PMID: 26312908 (View on PubMed)

Shah AD, Langenberg C, Rapsomaniki E, Denaxas S, Pujades-Rodriguez M, Gale CP, Deanfield J, Smeeth L, Timmis A, Hemingway H. Type 2 diabetes and incidence of cardiovascular diseases: a cohort study in 1.9 million people. Lancet Diabetes Endocrinol. 2015 Feb;3(2):105-13. doi: 10.1016/S2213-8587(14)70219-0. Epub 2014 Nov 11.

Reference Type: DERIVED

PMID: 25466521 (View on PubMed)

Other Identifiers

CALIBER 12_153R

Identifier Type: -

Identifier Source: org_study_id