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Clinical Trials/NCT02244853
NCT02244853UnknownNot Applicable

Association of Heart Rate With Cardiovascular Disease Prognosis of Patients With Stable Coronary Artery Disease: A CALIBER Study

University College, London1 site in 1 country51,703 target enrollmentStarted: September 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
51,703
Locations
1
Primary Endpoint
Risk of cardiovascular diseases in patients with low and high heart rate and stable coronary artery disease

Study Overview

Brief Summary

The Cardiovascular disease research using Linked Bespoke studies and Electronic Records (CALIBER) e-health database was the data resource for this study. CALIBER links patient records from four different data sources: Clinical Practice Research Database (CPRD), MINAP (Myocardial Ischaemia National Audit Project registry) Hospital Episodes Statistics (HES), the Office for National Statistics (ONS).

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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Aged >=30 years at study entry ->=1 year registration prior to the 'index date'

Exclusion Criteria

  • Free from previous atherosclerotic events
  • No heart rate measurement after their 'index date' of eligibility to entry the study

Outcomes

Primary Outcomes

Risk of cardiovascular diseases in patients with low and high heart rate and stable coronary artery disease

Time Frame: expected average of 3 years

Participants were followed until their first cardiovascular or complication event after their studyentry and after at least one previous cardiovascular event. Hazard ratios will be presenting associations between heart rate (analysed as quintiles and as continuous per 10bpm) and 8 different cardiovascular diseases (including mortality outcomes, complications such as bleeding events and composite cerebrovascular and coronary heart disease endpoints).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Harry Hemingway

Professor

University College, London

Study Sites (1)

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