Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

Wellcome Trust

National Institute for Health Research, United Kingdom

Information provided by (Responsible Party):

Harry Hemingway, University College, London

ClinicalTrials.gov Identifier:

NCT01947361

First received: September 12, 2013

Last updated: September 17, 2013

Last verified: September 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	September 12, 2013
Last Updated Date	September 17, 2013
Start Date ^ICMJE	January 2012
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (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) ] [ Designated as safety issue: No ] 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 ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01947361 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (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) ] [ Designated as safety issue: No ] 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 ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber)
Official Title ^ICMJE	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 ^ICMJE	Observational
Study Design ^ICMJE	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 ^ICMJE	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 ^ICMJE	Not Provided
Study Group/Cohort (s)	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 ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	1961286
Estimated Completion Date	December 2014
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	30 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	United Kingdom
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT01947361
Other Study ID Numbers ^ICMJE	12_153R_IP10, RP-PG-0407-10314
Has Data Monitoring Committee	Yes
Responsible Party	Harry Hemingway, University College, London
Study Sponsor ^ICMJE	University College, London
Collaborators ^ICMJE	Wellcome Trust National Institute for Health Research, United Kingdom
Investigators ^ICMJE	Not Provided
Information Provided By	University College, London
Verification Date	September 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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