Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes

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.

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Key information

Conditions

Heart Diseases Abdominal Aortic Aneurysm Acute Myocardial Infarction Aneurysm Angina Pectoris Angina, Stable Angina, Unstable Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Brain Diseases Brain Ischemia Cardiac Arrest Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Accident Cerebrovascular Disorders Chest Pain Chronic Stable Angina Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Failure Hemorrhage Hemorrhagic Stroke Infarction Intracranial Hemorrhages Ischemia Ischemic Attack, Transient Ischemic Stroke Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Stroke Subarachnoid Hemorrhage Sudden Coronary Death Sudden Death Transient Ischemic Attack Unstable Angina Vascular Diseases Ventricular Arrhythmia

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Time frame: 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.

Other outcomes

Cardiovascular heart disease and fatal cardiovascular disease

Time frame: Same as for primary endpoint (maximum of 13 years after follow-up start)

Cardiovascular heart disease: combination of MI and unheralded coronary death. Cardiovascular disease: combination of fatal cardiovascular heart disease and stroke of any type.

Fatal cardiovascular disease: combination of fatal coronary heart disease and fatal cardiovascular death.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

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

Important dates

Study start: 1997
Primary completion: 2010
Study completion: 2010
First posted: Mar 5, 2013
Registry last updated: Mar 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed