- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02244853
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
Status
Unknown
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
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London, United Kingdom, NW1 2DA
- Farr Institute, University College London
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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
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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).
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expected average of 3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pain
- Neurologic Manifestations
- Atherosclerosis
- Arrhythmias, Cardiac
- Death
- Infarction
- Chest Pain
- Angina Pectoris
- Heart Arrest
- Myocardial Infarction
- Heart Diseases
- Coronary Artery Disease
- Coronary Disease
- Cardiovascular Diseases
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Atrial Fibrillation
- Angina, Stable
- Death, Sudden, Cardiac
- Death, Sudden
Other Study ID Numbers
- 12_153R_IP24
- RP-PG-0407-10314 (Other Grant/Funding Number: Wellcome Trust)
- 086091/Z/08/Z (Other Grant/Funding Number: Wellcome Trust)
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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