Stable AnginaNCT02244853
Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease
An observational study of Stable Angina and Myocardial Infarction, run by University College, London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stable Angina, Myocardial Infarction, Coronary Heart Disease
- How many people
- 51,703 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Aged >=30 years at study entry ->=1 year registration prior to the 'index date'
Who cannot join
- Free from previous atherosclerotic events
- No heart rate measurement after their 'index date' of eligibility to entry the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Farr Institute, University College London
London, NW1 2DA
About this study
Official title: 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).
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).
- Conditions
- Stable Angina, Myocardial Infarction, Coronary Heart Disease, Heart Failure, Stroke, Death, Sudden, Cardiac
- Medical subject headings
- Angina, Stable, Myocardial Infarction, Coronary Disease, Heart Failure, Stroke, Death, Sudden, Cardiac, Peripheral Arterial Disease, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: expected average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51,703 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Harry Hemingway, University College, London
- Investigators
- Harry Hemingway, Professor, Study director, Farr Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244853
- Sponsor's protocol ID
- 12_153R_IP24
- Other IDs
- 086091/Z/08/Z, RP-PG-0407-10314
- Status last verified
- Sep 2014
- First submitted
- 17 Sep 2014
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Heart Rate With Cardiovascular Disease Prognosis of Patients With Stable Coronary Artery Disease: A CALIBER Study
- ClinicalTrials.gov ID
- NCT02244853
- Acronym / sponsor ID
- 12_153R_IP24
- Conditions
- Stable Angina, Myocardial Infarction, Coronary Heart Disease, Heart Failure, Stroke, Death, Sudden, Cardiac
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51,703 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Wellcome Trust, National Institute for Health Research, United Kingdom
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Aged >=30 years at study entry ->=1 year registration prior to the 'index date'
Key exclusion criteria (2 listed)
- Free from previous atherosclerotic events
- No heart rate measurement after their 'index date' of eligibility to entry the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harry Hemingway, Professor study director
Farr Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Angina and Myocardial Infarction, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk of cardiovascular diseases in patients with low and high heart rate and stable coronary artery disease (time frame: expected average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2014.