Clinical trial NCT01947361: Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber)
Official title: Heterogeneity in Association of Heart Rate and Initial Presentation of Cardiovascular Diseases Using Linked Electronic Health Records
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Aortic Aneurysm
Coronary Heart Disease NOS
Unheralded Coronary Death
Intracerebral Haemorrhage
Heart Failure
Ischemic Stroke
Myocardial Infarction
Stroke
Peripheral Arterial Disease
Stable Angina Pectoris
Subarachnoid Haemorrhage
Transient Ischemic Attack
Unstable Angina
Cardiac Arrest, Sudden Cardiac Death
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Wellcome Trust
name: National Institute for Health Research, United Kingdom
First posted: 2013-09-20
Enrollment: 1961286
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1,96 million patients registered in Clinical Practice Research Datalink (CPRD) practices

Brief summary: Study of heterogeneity in associations between heart rate and the initial presentation of 12 cardiovascular diseases.

Detailed description: This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

Eligibility criteria: Inclusion Criteria:

* One year prior to study entry (up-to-standard follow-up, CPRD quality research standard).
* \> 30 years old
* have at least a recorded heart rate measurement during the study period

Exclusion Criteria:

- Evidence of prior atherosclerotic or cardiac disease

Primary outcomes:
measure: Risk of atherosclerotic disease in patients with high or low heart rate
timeFrame: Participants were followed until the first Coronary disease event (an expected average of 5 years)
Secondary outcomes:
measure: Incidence proportions and life time risk for Cardiovascular diseases
timeFrame: Participants were followed until the first Coronary disease event (an expected average of 5 years)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
References:
citation: Archangelidi O, Pujades-Rodriguez M, Timmis A, Jouven X, Denaxas S, Hemingway H. Clinically recorded heart rate and incidence of 12 coronary, cardiac, cerebrovascular and peripheral arterial diseases in 233,970 men and women: A linked electronic health record study. Eur J Prev Cardiol. 2018 Sep;25(14):1485-1495. doi: 10.1177/2047487318785228. Epub 2018 Jul 2.