Abdominal Aortic AneurysmNCT01947361
Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber)
An observational study of Abdominal Aortic Aneurysm and Coronary Heart Disease NOS, run by University College, London at 1 site in United Kingdom.
Trial summary
Study of heterogeneity in associations between heart rate and the initial presentation of 12 cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Aortic Aneurysm, Coronary Heart Disease NOS, Unheralded Coronary Death
- How many people
- 1,961,286 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1,96 million patients registered in Clinical Practice Research Datalink (CPRD) practices
Who may be able to join
- One year prior to study entry (up-to-standard follow-up, CPRD quality research standard).
- > 30 years old
- have at least a recorded heart rate measurement during the study period
Who cannot join
- Evidence of prior atherosclerotic or cardiac disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heterogeneity in Association of Heart Rate and Initial Presentation of Cardiovascular Diseases Using Linked Electronic Health Records
Study of heterogeneity in associations between heart rate and the initial presentation of 12 cardiovascular diseases.
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
- Abdominal Aortic Aneurysm, Coronary Heart Disease NOS, Unheralded Coronary Death, Intracerebral Haemorrhage, Heart Failure, Ischemic Stroke
- Medical subject headings
- Aortic Aneurysm, Abdominal, Cerebral Hemorrhage, Heart Failure, Ischemic Stroke, Myocardial Infarction, Stroke, Peripheral Arterial Disease, Angina, Stable
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of atherosclerotic disease in patients with high or low heart rate
Hazard ratios will be also presenting associations between heart rate and initial presentation of different cardiovascular diseases. These associations will be also measured between different levels of heart rate and CVDs stratified by:
- by sex
- gender
- a range of risk factors (such as physical activity, smoking status, drinking status, etc.)
Measured: Participants were followed until the first Coronary disease event (an expected average of 5 years)
Secondary outcomes (1)
Incidence proportions and life time risk for Cardiovascular diseases
Subhazard Ratios and Cumulative Incidence estimation of the risk of 12 different cardiovascular diseases adjusted for the 4 different levels of heart rate (<60, 60-74, 75-89, >90), age and sex in a lifetime period
Measured: Participants were followed until the first Coronary disease event (an expected average of 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies 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
- Retrospective
- Enrolment
- 1,961,286 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947361
- Sponsor's protocol ID
- 12_153R_IP10
- Other IDs
- RP-PG-0407-10314
- Status last verified
- Sep 2013
- First submitted
- 12 Sep 2013
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Archangelidi O, Pujades-Rodriguez M, Timmis A, Jouven X, Denaxas S, Hemingway H. Clinically recorded heart rate and incidence of 12 coronary, cardiac, cerebrovascular and peripheral arterial diseases in 233,970 men and women: A linked electronic health record study. Eur J Prev Cardiol. 2018 Sep;25(14):1485-1495. doi: 10.1177/2047487318785228. Epub 2018 Jul 2.
PubMed 29966429
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heterogeneity in Association of Heart Rate and Initial Presentation of Cardiovascular Diseases Using Linked Electronic Health Records
- ClinicalTrials.gov ID
- NCT01947361
- Acronym / sponsor ID
- 12_153R_IP10
- Conditions
- Abdominal Aortic Aneurysm, Coronary Heart Disease NOS, Unheralded Coronary Death, Intracerebral Haemorrhage, Heart Failure, Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,961,286 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Wellcome Trust, National Institute for Health Research, United Kingdom
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 20 Sep 2013 (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.
Study of heterogeneity in associations between heart rate and the initial presentation of 12 cardiovascular diseases.
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
- Retrospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1,96 million patients registered in Clinical Practice Research Datalink (CPRD) practices
Key inclusion criteria (3 listed)
- One year prior to study entry (up-to-standard follow-up, CPRD quality research standard).
- > 30 years old
- have at least a recorded heart rate measurement during the study period
Key exclusion criteria (1 listed)
- Evidence of prior atherosclerotic or cardiac disease
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 atherosclerotic disease in patients with high or low heart rate
Time frame: Participants were followed until the first Coronary disease event (an expected average of 5 years)
Hazard ratios will be also presenting associations between heart rate and initial presentation of different cardiovascular diseases. These associations will be also measured between different levels of heart rate and CVDs stratified by: * by sex * gender * a range of risk factors (such as physical activity, smoking status, drinking status, etc.)
1 secondary outcome
Incidence proportions and life time risk for Cardiovascular diseases
Time frame: Participants were followed until the first Coronary disease event (an expected average of 5 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
- Derived from this study: PubMed 29966429Archangelidi O, Pujades-Rodriguez M, Timmis A, Jouven X, Denaxas S, Hemingway H. Clinically recorded heart rate and incidence of 12 coronary, cardiac, cerebrovascular and peripheral arterial diseases in 233,970 men and women: A linked electronic health record study. Eur J Prev Cardiol. 2018 Sep;25(14):1485-1495. doi: 10.1177/2047487318785228. Epub 2018 Jul 2.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Abdominal Aortic Aneurysm and Coronary Heart Disease NOS, 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 3 inclusion and 1 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 20 Sep 2013. 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 atherosclerotic disease in patients with high or low heart rate (time frame: Participants were followed until the first Coronary disease event (an expected average of 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01947361, which also lists 1 linked publication.
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 20 Sep 2013.