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

September 18, 2014 updated by: Harry Hemingway, University College, London

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

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).

Study Overview

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 Type

Observational

Enrollment (Actual)

51703

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
expected average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Harry Hemingway, Professor, Farr Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

September 17, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Estimate)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 18, 2014

Last Verified

September 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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