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

September 12, 2013
September 17, 2013
January 2012
December 2013   (final data collection date for primary outcome measure)
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.)
Same as current
Complete list of historical versions of study NCT01947361 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber)
Heterogeneity in Association of Heart Rate and Initial Presentation of Cardiovascular Diseases Using Linked Electronic Health Records

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

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).

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

1,96 million patients registered in Clinical Practice Research Datalink (CPRD) practices

  • 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
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1961286
December 2014
December 2013   (final data collection date for primary outcome measure)

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

Both
30 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01947361
12_153R_IP10, RP-PG-0407-10314
Yes
Harry Hemingway, University College, London
University College, London
  • Wellcome Trust
  • National Institute for Health Research, United Kingdom
Not Provided
University College, London
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP