Clinical trial NCT01804439: Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes
Official title: Cardiovascular Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes: a CALIBER Proposal Using Linked GPRD-MINAP-HES Data
Study type: OBSERVATIONAL
Overall status: 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
Peripheral Arterial Disease
Sudden Coronary Death
Ventricular Arrhythmia
Sudden Death
Cardiac Arrest
Heart Failure
Keywords: Heart diseases
Cardiovascular diseases
Coronary heart disease not otherwise specified
Cerebrovascular disorders
Brain diseases
Central nervous system diseases
Nervous system diseases
Atherosclerosis
Arteriosclerosis
Pathologic processes
Acute myocardial infarction
Myocardial infarction
Myocardial ischemia
Infarction
Necrosis
Unstable angina
Chronic stable angina
Stable angina
Angina pectoris
Chest pain
Pain
Signs and symptoms
Ischemia
Ischemic stroke
Hemorrhagic stroke
Stroke
Subarachnoid hemorrhage
Transient ischemic attack
Abdominal aortic aneurysm
Aneurysm
Aortic aneurysm
Aortic aneurysm, abdominal
Aortic diseases
Peripheral arterial diseases
Peripheral vascular diseases
Vascular diseases
Peripheral occlusive diseases
Sudden coronary death
Ventricular arrhythmia
Sudden cardiac death
Cardiac arrest
Heart failure
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2013-03-05
Enrollment: 2240000
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include all patients aged ≥30yrs old, registered in CPRD practices in England consenting to data linkage, with at least 1 year of up-to-standard pre-study follow-up and no history of any of the CVD endpoints considered. Follow-up for endpoints will commence on the earliest date on which a patient fulfils the criteria, within the period between 1st January 1997 and 25th March 2010.

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.


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.

Primary outcomes:
measure: First presentation of cardiovascular disease, as specified in description
timeFrame: 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).
Secondary outcomes:
measure: Non CVD specific deaths
timeFrame: Same as for primary outcomes (maximum of 13 years after follow-up start)
Other outcomes:
measure: Cardiovascular heart disease and fatal cardiovascular disease
timeFrame: Same as for primary endpoint (maximum of 13 years after follow-up start)
Locations:
Study officials:
References:
citation: 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.
citation: 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.