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
  Purpose

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


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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • 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.)


Secondary Outcome Measures:
  • 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


Enrollment: 1961286
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947361

Locations
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

Additional Information:
No publications provided

Responsible Party: Harry Hemingway, Professor, University College, London
ClinicalTrials.gov Identifier: NCT01947361     History of Changes
Other Study ID Numbers: 12_153R_IP10, RP-PG-0407-10314
Study First Received: September 12, 2013
Last Updated: September 17, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Aneurysm
Angina Pectoris
Angina, Unstable
Aortic Aneurysm
Cardiovascular Diseases
Ischemic Attack, Transient
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Death
Heart Arrest
Heart Diseases
Heart Failure
Hemorrhage
Infarction
Ischemia
Myocardial Infarction
Stroke
Cerebral Infarction
Subarachnoid Hemorrhage
Peripheral Arterial Disease
Peripheral Vascular Diseases
Death, Sudden, Cardiac
Aortic Aneurysm, Abdominal
Cerebral Hemorrhage
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Aortic Diseases

ClinicalTrials.gov processed this record on July 22, 2014