Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber)

Tracking Information
First Submitted Date	September 12, 2013
First Posted Date	September 20, 2013
Last Update Posted Date	September 20, 2013
Study Start Date	January 2012
Estimated Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: September 17, 2013)	Risk of atherosclerotic disease in patients with high or low heart rate [ Time Frame: Participants were followed until the first Coronary disease event (an expected average of 5 years) ]; Hazard ratios will be also presenting associations between heart rate and initial presentation of different cardiovascular diseases. These associations will be also measured between different levels of heart rate and CVDs stratified by: by sex; gender; a range of risk factors (such as physical activity, smoking status, drinking status, etc.)
Original Primary Outcome Measures	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures; (submitted: September 17, 2013)	Incidence proportions and life time risk for Cardiovascular diseases [ Time Frame: Participants were followed until the first Coronary disease event (an expected average of 5 years) ]; Subhazard Ratios and Cumulative Incidence estimation of the risk of 12 different cardiovascular diseases adjusted for the 4 different levels of heart rate (<60, 60-74, 75-89, >90), age and sex in a lifetime period
Original Secondary Outcome Measures	Same as current
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	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
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).
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	1,96 million patients registered in Clinical Practice Research Datalink (CPRD) practices
Condition	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
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Unknown status
Actual Enrollment; (submitted: September 17, 2013)	1961286
Original Actual Enrollment	Same as current
Estimated Study Completion Date	December 2014
Estimated Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
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
Sex/Gender	Sexes Eligible for Study: All
Ages	30 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United Kingdom
Removed Location Countries
Administrative Information
NCT Number	NCT01947361
Other Study ID Numbers	12_153R_IP10; RP-PG-0407-10314 ( Other Grant/Funding Number: Wellcome Trust )
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Harry Hemingway, University College, London
Study Sponsor	University College, London
Collaborators	Wellcome Trust; National Institute for Health Research, United Kingdom
Investigators	Not Provided
PRS Account	University College, London
Verification Date	September 2013