Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes
|ClinicalTrials.gov Identifier: NCT01804439|
Recruitment Status : Completed
First Posted : March 5, 2013
Last Update Posted : March 5, 2013
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.
|Condition or disease|
|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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||2240000 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||Cardiovascular Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes: a CALIBER Proposal Using Linked GPRD-MINAP-HES Data|
|Study Start Date :||January 1997|
|Primary Completion Date :||March 2010|
|Study Completion Date :||March 2010|
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).
- 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
- 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.
- 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.