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Status unknownNCT02244853Updated Sep 19, 2014

Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease

An observational study in Stable Angina, Myocardial Infarction and Coronary Heart Disease, sponsored by University College, London. Status unknown at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2014-09-19.

Sponsored by University College, London · Observational

The sponsor has not verified this record recently (last verified Sep 2014), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
51,703
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Study 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).

Read the 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).

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Conditions studied

  • Stable Angina
  • Myocardial Infarction
  • Coronary Heart Disease
  • Heart Failure
  • Stroke
  • Death, Sudden, Cardiac
  • Peripheral Arterial Disease
  • Atrial Fibrillation
  • Bleeding
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In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 51,703 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

An open cohort of 2,23 million people covering approximately 5% of the UK population was drawn from registrants to 225 GP practices who consented to data linkage.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
51,703 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

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

    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).

    Time frame: expected average of 3 years

07

Study locations

1 site
  • Farr Institute, University College London
    London, NW1 2DA, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02244853
Lead sponsor
University College, London
Collaborators
Wellcome Trust, National Institute for Health Research, United Kingdom
Responsible party
Harry Hemingway (Professor, University College, London) — Principal investigator
First posted
Sep 19, 2014
Start date
Sep 2013
Primary completion
Dec 2013
Completion
Dec 2014 (estimated)
Last update
Sep 19, 2014

Study contacts

Harry Hemingway, Professor
study director · Farr Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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