Heart DiseasesNCT01804439
Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes
An observational study of Heart Diseases and Cardiovascular Diseases, run by University College, London.
Trial summary
Cardiovascular disease (CVD) is an important public health problem that affects millions of people worldwide. Associations between risk factors, such as smoking, dyslipidaemia or hypertension, and prevalent CVD are well documented. However, few studies have investigated associations with onset of disease. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases, Cardiovascular Diseases, Acute Myocardial Infarction
- How many people
- 2,240,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 1997to Mar 2010
- How long will I take part?
- 10 Years
- 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: The study population will include all patients aged ≥30yrs old, registered in CPRD practices in England consenting to data linkage, with at least 1 year of up-to-standard pre-study follow-up and no history of any of the CVD endpoints considered. Follow-up for endpoints will commence on the earliest date on which a patient fulfils the criteria, within the period between 1st January 1997 and 25th March 2010.
Who may be able to join
- Aged ≥30yrs old
- Registered in CPRD practices in England consenting to data linkage
- ≥1 year of up-to-standard pre-study follow-up
Who cannot join
- History of any of the CVD endpoints considered before study follow-up initiation.
About this study
Official title: Cardiovascular Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes: a CALIBER Proposal Using Linked GPRD-MINAP-HES Data
Cardiovascular disease (CVD) is an important public health problem that affects millions of people worldwide. Associations between risk factors, such as smoking, dyslipidaemia or hypertension, and prevalent CVD are well documented. However, few studies have investigated associations with onset of disease. The initial manifestation of CVD, for example an episode of unstable angina, is important because it influences the prognosis, the quality of life and the management of disease. Furthermore, the extent to which social deprivation, alcohol consumption or atrial fibrillation affects presentation of CVD is poorly understood and deserves further consideration.
Most previous studies have considered CVD as a single entity. However, differences in aetiology between coronary phenotypes suggest that risk factors may not be shared across specific coronary phenotypes and their relative importance is likely to differ for each phenotype. Gaining knowledge of these differences could provide insights into the pathophysiology of specific forms of CVD and could eventually lead to modification of recommendations for patient management and disease prevention.
We propose to use the linkage of the national registry of coronary events to general practice records in the Clinical Practice Research Database (CPRD), to investigate whether demographic, behavioral, and clinico-metabolic risk factors differentially influence the onset of specific types of CVD.
- Conditions
- Heart Diseases, Cardiovascular Diseases, Acute Myocardial Infarction, Unstable Angina, Chronic Stable Angina, Ischemic Stroke
- Keywords
- Heart diseases, Cardiovascular diseases, Coronary heart disease not otherwise specified, Cerebrovascular disorders, Brain diseases, Central nervous system diseases, Nervous system diseases, Atherosclerosis, Arteriosclerosis, Pathologic processes, Acute myocardial infarction, Myocardial infarction, Myocardial ischemia, Infarction, Necrosis, Unstable angina, Chronic stable angina, Stable angina, Angina pectoris, Chest pain
- Medical subject headings
- Heart Diseases, Cardiovascular Diseases, Angina, Unstable, Angina, Stable, Ischemic Stroke, Stroke, Subarachnoid Hemorrhage, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CALIBER Healthy Cohort | We will report findings from the CALIBER (CArdiovascular disease research using Linked BEspoke studies and Electronic Records) collaboration where we linked primary care data (from the General Practice Research Database [GPRD]) to three further sources of electronic health records: the Myocardial Ischemia National Audit Project registry (MINAP),cause specific discharge data from Hospital Episodes Statistics (HES) and cause specific mortality from the Office for National Statistics (ONS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
First presentation of cardiovascular disease, as specified in description
First occurrence of the following fatal or non-fatal cardiovascular outcomes: acute myocardial infarction, unstable angina, stable angina, ischemic stroke, hemorrhagic stroke, subarachnoid hemorrhage, transient ischemic attack, abdominal aortic aneurysm, peripheral arterial disease, sudden cardiac death, heart failure
Measured: Study follow-up will commence on the earliest date on which a patient fulfils the criteria for study inclusion within the period between 1st January 1997 and 25th March 2010 (maximum of 13 years after enrolment).
Secondary outcomes (1)
Non CVD specific deaths
Death from non CVD, that is, excluding deaths related to the primary endpoints.
Measured: Same as for primary outcomes (maximum of 13 years after follow-up start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startJan 1997
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies 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
- 2,240,000 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harry Hemingway, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804439
- Sponsor's protocol ID
- CALIBER 12_153R
- Status last verified
- Mar 2013
- First submitted
- 8 Jan 2013
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Dinesh Shah A, Langenberg C, Rapsomaniki E, Denaxas S, Pujades-Rodriguez M, Gale CP, Deanfield J, Smeeth L, Timmis A, Hemingway H. Type 2 diabetes and incidence of a wide range of cardiovascular diseases: a cohort study in 1.9 million people. Lancet. 2015 Feb 26;385 Suppl 1:S86. doi: 10.1016/S0140-6736(15)60401-9.
PubMed 26312908Shah AD, Langenberg C, Rapsomaniki E, Denaxas S, Pujades-Rodriguez M, Gale CP, Deanfield J, Smeeth L, Timmis A, Hemingway H. Type 2 diabetes and incidence of cardiovascular diseases: a cohort study in 1.9 million people. Lancet Diabetes Endocrinol. 2015 Feb;3(2):105-13. doi: 10.1016/S2213-8587(14)70219-0. Epub 2014 Nov 11.
PubMed 25466521
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes: a CALIBER Proposal Using Linked GPRD-MINAP-HES Data
- ClinicalTrials.gov ID
- NCT01804439
- Acronym / sponsor ID
- CALIBER 12_153R
- Conditions
- Heart Diseases, Cardiovascular Diseases, Acute Myocardial Infarction, Unstable Angina, Chronic Stable Angina, Ischemic Stroke
- Keywords
- Heart diseases, Cardiovascular diseases, Coronary heart disease not otherwise specified, Cerebrovascular disorders, Brain diseases, Central nervous system diseases, Nervous system diseases, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,240,000 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Jan 1997
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 5 Mar 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.
Cardiovascular disease (CVD) is an important public health problem that affects millions of people worldwide. Associations between risk factors, such as smoking, dyslipidaemia or hypertension, and prevalent CVD are well documented. However, few studies have investigated associations with onset of disease. The initial manifestation of CVD, for example an episode of unstable angina, is important because it influences the prognosis, the quality of life and the management of disease. Furthermore, the extent to which social deprivation, alcohol consumption or atrial fibrillation affects presentation of CVD is poorly understood and deserves further consideration.
Most previous studies have considered CVD as a single entity. However, differences in aetiology between coronary phenotypes suggest that risk factors may not be shared across specific coronary phenotypes and their relative importance is likely to differ for each phenotype. Gaining knowledge of these differences could provide insights into the pathophysiology of specific forms of CVD and could eventually lead to modification of recommendations for patient management and disease prevention.
We propose to use the linkage of the national registry of coronary events to general practice records in the Clinical Practice Research Database (CPRD), to investigate whether demographic, behavioral, and clinico-metabolic risk factors differentially influence the onset of specific types of CVD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CALIBER Healthy Cohort | – | –We will report findings from the CALIBER (CArdiovascular disease research using Linked BEspoke studies and Electronic Records) collaboration where we linked primary care data (from the General Practice Research Database [GPRD]) to three further sources of electronic health records: the Myocardial Ischemia National Audit Project registry (MINAP),cause specific discharge data from Hospital Episodes Statistics (HES) and cause specific mortality from the Office for National Statistics (ONS). |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include all patients aged ≥30yrs old, registered in CPRD practices in England consenting to data linkage, with at least 1 year of up-to-standard pre-study follow-up and no history of any of the CVD endpoints considered. Follow-up for endpoints will commence on the earliest date on which a patient fulfils the criteria, within the period between 1st January 1997 and 25th March 2010.
Key inclusion criteria (3 listed)
- Aged ≥30yrs old
- Registered in CPRD practices in England consenting to data linkage
- ≥1 year of up-to-standard pre-study follow-up
Key exclusion criteria (1 listed)
- History of any of the CVD endpoints considered before study follow-up initiation.
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
First presentation of cardiovascular disease, as specified in description
Time frame: Study follow-up will commence on the earliest date on which a patient fulfils the criteria for study inclusion within the period between 1st January 1997 and 25th March 2010 (maximum of 13 years after enrolment).
First occurrence of the following fatal or non-fatal cardiovascular outcomes: acute myocardial infarction, unstable angina, stable angina, ischemic stroke, hemorrhagic stroke, subarachnoid hemorrhage, transient ischemic attack, abdominal aortic aneurysm, peripheral arterial disease, sudden cardiac death, heart failure
1 secondary outcome
Non CVD specific deaths
Time frame: Same as for primary outcomes (maximum of 13 years after follow-up start)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
- Derived from this study: PubMed 26312908Dinesh Shah A, Langenberg C, Rapsomaniki E, Denaxas S, Pujades-Rodriguez M, Gale CP, Deanfield J, Smeeth L, Timmis A, Hemingway H. Type 2 diabetes and incidence of a wide range of cardiovascular diseases: a cohort study in 1.9 million people. Lancet. 2015 Feb 26;385 Suppl 1:S86. doi: 10.1016/S0140-6736(15)60401-9.
- Derived from this study: PubMed 25466521Shah AD, Langenberg C, Rapsomaniki E, Denaxas S, Pujades-Rodriguez M, Gale CP, Deanfield J, Smeeth L, Timmis A, Hemingway H. Type 2 diabetes and incidence of cardiovascular diseases: a cohort study in 1.9 million people. Lancet Diabetes Endocrinol. 2015 Feb;3(2):105-13. doi: 10.1016/S2213-8587(14)70219-0. Epub 2014 Nov 11.
Related trials for Heart Diseases
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and Cardiovascular Diseases, run by University College, London.
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: finished, as of the sponsor's last update on 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
First presentation of cardiovascular disease, as specified in description (time frame: Study follow-up will commence on the earliest date on which a patient fulfils the criteria for study inclusion within the period between 1st January 1997 and 25th March 2010 (maximum of 13 years after enrolment).). 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 NCT01804439, which also lists 2 linked publications.
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 5 Mar 2013.