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Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease
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

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 Design
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Study Type : Observational
Actual Enrollment : 1961286 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Heterogeneity in Association of Heart Rate and Initial Presentation of Cardiovascular Diseases Using Linked Electronic Health Records
Study Start Date : January 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.)


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
1,96 million patients registered in Clinical Practice Research Datalink (CPRD) practices
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947361


Locations
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United Kingdom
University College London
London, United Kingdom, WC1E 7H
Sponsors and Collaborators
University College, London
Wellcome Trust
National Institute for Health Research, United Kingdom
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Harry Hemingway, Professor, University College, London
ClinicalTrials.gov Identifier: NCT01947361    
Other Study ID Numbers: 12_153R_IP10
RP-PG-0407-10314 ( Other Grant/Funding Number: Wellcome Trust )
First Posted: September 20, 2013    Key Record Dates
Last Update Posted: September 20, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Subarachnoid Hemorrhage
Cerebral Hemorrhage
Ischemic Attack, Transient
Cardiovascular Diseases
Myocardial Infarction
Angina Pectoris
Aortic Aneurysm
Peripheral Arterial Disease
Peripheral Vascular Diseases
Coronary Disease
Aortic Aneurysm, Abdominal
Angina, Stable
Death, Sudden, Cardiac
 Angina, Unstable
Ischemia
Hemorrhage
Death
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Heart Diseases
Pathologic Processes
Infarction
Necrosis
Myocardial Ischemia
Aneurysm