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Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber)

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ClinicalTrials.gov Identifier: NCT01947361
Recruitment Status : Unknown
Verified September 2013 by Harry Hemingway, University College, London.
Recruitment status was:  Active, not recruiting
First Posted : September 20, 2013
Last Update Posted : September 20, 2013
Sponsor:
Collaborators:
Wellcome Trust
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Harry Hemingway, University College, London

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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified 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 * 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.

*   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, Older Adult)
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