Coronary DiseaseNCT01164371
Gender Differences in the Development, Treatment and Prognosis of Coronary Disease: A CALIBER Study
An observational study of Coronary Disease and Cardiovascular Disease, run by University College, London.
Trial summary
The initial manifestation of symptomatic coronary disease can range from angina (or symptoms of angina), unheralded acute coronary syndrome (ACS), or unheralded coronary death. A better understanding of gender differences in initial presentation of coronary disease and the rate and predictors of progression to… Read more about this study
- Who is it for?
- Ages 35 to 100 years
- Conditions the study is for
- Coronary Disease, Cardiovascular Disease
- How many people
- 1,758,584 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to Nov 2013
- 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 35 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include all adults aged 35 or over in General Practice Research Database (GPRD), registered with an up-to-standard practice with at least 1 year of continuous follow-up. Further details on defining up-to-standard practices within GPRD are available from http://www.gprd.com/home/
Who may be able to join
- as above
Who cannot join
- patients with a history of ischaemic heart disease, heart failure, cerebrovascular disease, peripheral arterial disease or congenital coronary anomalies, prior to entry into the cohort
- patients with symptoms of chest pain in the 6 months prior to cohort entry
- patients < 35 or >100 years of age after eligibility for entry to the cohort
About this study
Official title: Gender Differences in the Development and Prognosis of Coronary Disease Where Initial Disease Manifestation is Stable Angina, Myocardial Infarction or Unheralded Coronary Death: A CALIBER Study Using Linked GPRD-MINAP Data
The initial manifestation of symptomatic coronary disease can range from angina (or symptoms of angina), unheralded acute coronary syndrome (ACS), or unheralded coronary death. A better understanding of gender differences in initial presentation of coronary disease and the rate and predictors of progression to subsequent stages in coronary disease could help to identify which gender- specific factors might reduce or slow transition to more serious disease states and improve outcomes. The investigators' research focuses on the role primary care management of cardiovascular risk factors plays in gender differences in the progression to subsequent disease states and to mortality.
Read the detailed description
The initial manifestation of symptomatic coronary disease can range from angina (or symptoms of angina), unheralded acute coronary syndrome, or unheralded coronary death. Gender differences in initial presentation of coronary disease and the rate and predictors of progression to subsequent stages in coronary disease are not well understood. Furthermore, while the management of coronary risk factors in primary care is hypothesized to play a key role in the rate and timing of such transitions, little is known about the impact such management has on gender differences these transitions and outcomes.
Study Objectives:
- To determine gender differences in probabilities of transitions from symptom-free state to mortality for each of three patient coronary disease pathways, where the initial disease manifestation is angina, myocardial infarction or unheralded coronary death.
- To determine the role management of coronary risk factors in primary care has in explaining any gender differences in transitions from symptom-free state to mortality for each of the three patient coronary disease pathways.
A statistical analytic protocol for the first part of this study, comparing patients with unheralded coronary death to patients free of symptomatic coronary disease, dated June 2010, is available on request. A second statistical analytic protocol for the second part of this study, comparing initial presentation of coronary disease, within a framework of competing risks of atherosclerotic disease, dated December 2011, is available on request.
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
- Coronary Disease, Cardiovascular Disease
- Keywords
- coronary disease, cardiovascular disease, cardiovascular risk, cardiovascular risk management, primary care, angina, stable angina, angina pectoris, acute coronary syndrome, coronary death, unheralded acute coronary syndrome, unheralded coronary death, gender differences, sex differences, myocardial infarction, ST elevation myocardial infarction, non ST elevation myocardial infarction, STEMI, nSTEMI, unstable angina
- Medical subject headings
- Coronary Disease, Cardiovascular Diseases, Angina Pectoris, Angina, Stable, Acute Coronary Syndrome, Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
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 |
|---|---|---|
| Initial presentation of coronary disease - Stable angina | Patients whose initial symptomatic presentation of coronary disease is stable angina (either diagnosis or symptoms) | |
| Initial presentation of coronary disease - ACS | Patients whose initial symptomatic presentation of coronary disease is acute coronary syndrome (ST-elevation myocardial infarction [STEMI], non-STEMI [nSTEMI] or unstable angina) without prior stable angina or symptoms of stable angina | |
| Initial presentation of coronary disease - Coronary death | Patients whose initial symptomatic manifestation of coronary disease is coronary death with no prior diagnosis of stable angina (or symptoms of stable angina) or diagnosis of acute coronary syndrome | |
| Initial presentation of coronary disease - None | Patients without symptomatic presentation of coronary disease, either alive or dead from non-coronary cause |
What is being measured
The primary outcome is the main question the study is designed to answer.
coronary mortality (ICD 10 I20-I25)
coronary mortality, following symptom free state, diagnosed angina or acute coronary syndrome
Measured: up to 15 years from entry into cohort
Secondary outcomes (2)
stable angina
diagnosis of angina following symptom free state
Measured: up to 15 years from entry into cohort
acute non-fatal acute coronary syndrome, comprising ST elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina
acute coronary syndrome following either symptom-free state (unheralded) or stable angina
Measured: up to 15 years from entry into cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies 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
- 1,758,584 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Barts and the London School of Medicine and Dentistry, London School of Hygiene and Tropical Medicine
- Responsible party
- Principal investigator, Julie George, University College, London
- Investigators
- Julie George, MSc, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164371
- Sponsor's protocol ID
- CALIBER-09-05
- Status last verified
- May 2016
- First submitted
- 15 Jul 2010
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Permissions to used anonymised linked data from data owners prohibit further sharing of the data
Publications
Richards H, McConnachie A, Morrison C, Murray K, Watt G. Social and gender variation in the prevalence, presentation and general practitioner provisional diagnosis of chest pain. J Epidemiol Community Health. 2000 Sep;54(9):714-8. doi: 10.1136/jech.54.9.714.
PubMed 10942455Hemingway H, Langenberg C, Damant J, Frost C, Pyorala K, Barrett-Connor E. Prevalence of angina in women versus men: a systematic review and meta-analysis of international variations across 31 countries. Circulation. 2008 Mar 25;117(12):1526-36. doi: 10.1161/CIRCULATIONAHA.107.720953. Epub 2008 Mar 17.
PubMed 18347213Hemingway H, McCallum A, Shipley M, Manderbacka K, Martikainen P, Keskimaki I. Incidence and prognostic implications of stable angina pectoris among women and men. JAMA. 2006 Mar 22;295(12):1404-11. doi: 10.1001/jama.295.12.1404.
PubMed 16551712Buckley BS, Simpson CR, McLernon DJ, Murphy AW, Hannaford PC. Five year prognosis in patients with angina identified in primary care: incident cohort study. BMJ. 2009 Aug 6;339:b3058. doi: 10.1136/bmj.b3058.
PubMed 19661139Daly C, Clemens F, Lopez Sendon JL, Tavazzi L, Boersma E, Danchin N, Delahaye F, Gitt A, Julian D, Mulcahy D, Ruzyllo W, Thygesen K, Verheugt F, Fox KM; Euro Heart Survey Investigators. Gender differences in the management and clinical outcome of stable angina. Circulation. 2006 Jan 31;113(4):490-8. doi: 10.1161/CIRCULATIONAHA.105.561647.
PubMed 16449728Murabito JM, Evans JC, Larson MG, Levy D. Prognosis after the onset of coronary heart disease. An investigation of differences in outcome between the sexes according to initial coronary disease presentation. Circulation. 1993 Dec;88(6):2548-55. doi: 10.1161/01.cir.88.6.2548.
PubMed 8252666Yawn BP, Wollan PC, Jacobsen SJ, Fryer GE, Roger VL. Identification of women's coronary heart disease and risk factors prior to first myocardial infarction. J Womens Health (Larchmt). 2004 Dec;13(10):1087-100. doi: 10.1089/jwh.2004.13.1087.
PubMed 15650342Champney KP, Frederick PD, Bueno H, Parashar S, Foody J, Merz CN, Canto JG, Lichtman JH, Vaccarino V; NRMI Investigators. The joint contribution of sex, age and type of myocardial infarction on hospital mortality following acute myocardial infarction. Heart. 2009 Jun;95(11):895-9. doi: 10.1136/hrt.2008.155804. Epub 2009 Jan 15.
PubMed 19147625Vaccarino V, Parsons L, Peterson ED, Rogers WJ, Kiefe CI, Canto J. Sex differences in mortality after acute myocardial infarction: changes from 1994 to 2006. Arch Intern Med. 2009 Oct 26;169(19):1767-74. doi: 10.1001/archinternmed.2009.332.
PubMed 19858434MacIntyre K, Stewart S, Capewell S, Chalmers JW, Pell JP, Boyd J, Finlayson A, Redpath A, Gilmour H, McMurray JJ. Gender and survival: a population-based study of 201,114 men and women following a first acute myocardial infarction. J Am Coll Cardiol. 2001 Sep;38(3):729-35. doi: 10.1016/s0735-1097(01)01465-6.
PubMed 11527625George J, Rapsomaniki E, Pujades-Rodriguez M, Shah AD, Denaxas S, Herrett E, Smeeth L, Timmis A, Hemingway H. How Does Cardiovascular Disease First Present in Women and Men? Incidence of 12 Cardiovascular Diseases in a Contemporary Cohort of 1,937,360 People. Circulation. 2015 Oct 6;132(14):1320-8. doi: 10.1161/CIRCULATIONAHA.114.013797. Epub 2015 Sep 1.
PubMed 26330414Rapsomaniki E, Timmis A, George J, Pujades-Rodriguez M, Shah AD, Denaxas S, White IR, Caulfield MJ, Deanfield JE, Smeeth L, Williams B, Hingorani A, Hemingway H. Blood pressure and incidence of twelve cardiovascular diseases: lifetime risks, healthy life-years lost, and age-specific associations in 1.25 million people. Lancet. 2014 May 31;383(9932):1899-911. doi: 10.1016/S0140-6736(14)60685-1.
PubMed 24881994
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Differences in the Development and Prognosis of Coronary Disease Where Initial Disease Manifestation is Stable Angina, Myocardial Infarction or Unheralded Coronary Death: A CALIBER Study Using Linked GPRD-MINAP Data
- ClinicalTrials.gov ID
- NCT01164371
- Acronym / sponsor ID
- CALIBER-09-05
- Conditions
- Coronary Disease, Cardiovascular Disease
- Keywords
- coronary disease, cardiovascular disease, cardiovascular risk, cardiovascular risk management, primary care, angina, stable angina, angina pectoris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,758,584 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Barts and the London School of Medicine and Dentistry, London School of Hygiene and Tropical Medicine
- Study start
- Jul 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 16 Jul 2010 (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 initial manifestation of symptomatic coronary disease can range from angina (or symptoms of angina), unheralded acute coronary syndrome (ACS), or unheralded coronary death. A better understanding of gender differences in initial presentation of coronary disease and the rate and predictors of progression to subsequent stages in coronary disease could help to identify which gender- specific factors might reduce or slow transition to more serious disease states and improve outcomes. The investigators' research focuses on the role primary care management of cardiovascular risk factors plays in gender differences in the progression to subsequent disease states and to mortality.
Detailed description
The initial manifestation of symptomatic coronary disease can range from angina (or symptoms of angina), unheralded acute coronary syndrome, or unheralded coronary death. Gender differences in initial presentation of coronary disease and the rate and predictors of progression to subsequent stages in coronary disease are not well understood. Furthermore, while the management of coronary risk factors in primary care is hypothesized to play a key role in the rate and timing of such transitions, little is known about the impact such management has on gender differences these transitions and outcomes.
Study Objectives:
- To determine gender differences in probabilities of transitions from symptom-free state to mortality for each of three patient coronary disease pathways, where the initial disease manifestation is angina, myocardial infarction or unheralded coronary death.
- To determine the role management of coronary risk factors in primary care has in explaining any gender differences in transitions from symptom-free state to mortality for each of the three patient coronary disease pathways.
A statistical analytic protocol for the first part of this study, comparing patients with unheralded coronary death to patients free of symptomatic coronary disease, dated June 2010, is available on request. A second statistical analytic protocol for the second part of this study, comparing initial presentation of coronary disease, within a framework of competing risks of atherosclerotic disease, dated December 2011, is available on request.
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
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Initial presentation of coronary disease - Stable angina | – | –Patients whose initial symptomatic presentation of coronary disease is stable angina (either diagnosis or symptoms) |
| Initial presentation of coronary disease - ACS | – | –Patients whose initial symptomatic presentation of coronary disease is acute coronary syndrome (ST-elevation myocardial infarction [STEMI], non-STEMI [nSTEMI] or unstable angina) without prior stable angina or symptoms of stable angina |
| Initial presentation of coronary disease - Coronary death | – | –Patients whose initial symptomatic manifestation of coronary disease is coronary death with no prior diagnosis of stable angina (or symptoms of stable angina) or diagnosis of acute coronary syndrome |
| Initial presentation of coronary disease - None | – | –Patients without symptomatic presentation of coronary disease, either alive or dead from non-coronary cause |
Who may qualify
- Ages
- 35 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include all adults aged 35 or over in General Practice Research Database (GPRD), registered with an up-to-standard practice with at least 1 year of continuous follow-up. Further details on defining up-to-standard practices within GPRD are available from http://www.gprd.com/home/
Key inclusion criteria (1 listed)
- as above
Key exclusion criteria (3 listed)
- patients with a history of ischaemic heart disease, heart failure, cerebrovascular disease, peripheral arterial disease or congenital coronary anomalies, prior to entry into the cohort
- patients with symptoms of chest pain in the 6 months prior to cohort entry
- patients < 35 or >100 years of age after eligibility for entry to the cohort
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
coronary mortality (ICD 10 I20-I25)
Time frame: up to 15 years from entry into cohort
coronary mortality, following symptom free state, diagnosed angina or acute coronary syndrome
2 secondary outcomes
stable angina
Time frame: up to 15 years from entry into cohort
acute non-fatal acute coronary syndrome, comprising ST elevation myocardial infarction, non-ST elevation myocardial infarction, and unstable angina
Time frame: up to 15 years from entry into cohort
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 12 May 2016.
- Background: PubMed 10942455Richards H, McConnachie A, Morrison C, Murray K, Watt G. Social and gender variation in the prevalence, presentation and general practitioner provisional diagnosis of chest pain. J Epidemiol Community Health. 2000 Sep;54(9):714-8. doi: 10.1136/jech.54.9.714.
- Background: PubMed 18347213Hemingway H, Langenberg C, Damant J, Frost C, Pyorala K, Barrett-Connor E. Prevalence of angina in women versus men: a systematic review and meta-analysis of international variations across 31 countries. Circulation. 2008 Mar 25;117(12):1526-36. doi: 10.1161/CIRCULATIONAHA.107.720953. Epub 2008 Mar 17.
- Background: PubMed 16551712Hemingway H, McCallum A, Shipley M, Manderbacka K, Martikainen P, Keskimaki I. Incidence and prognostic implications of stable angina pectoris among women and men. JAMA. 2006 Mar 22;295(12):1404-11. doi: 10.1001/jama.295.12.1404.
- Background: PubMed 19661139Buckley BS, Simpson CR, McLernon DJ, Murphy AW, Hannaford PC. Five year prognosis in patients with angina identified in primary care: incident cohort study. BMJ. 2009 Aug 6;339:b3058. doi: 10.1136/bmj.b3058.
- Background: PubMed 16449728Daly C, Clemens F, Lopez Sendon JL, Tavazzi L, Boersma E, Danchin N, Delahaye F, Gitt A, Julian D, Mulcahy D, Ruzyllo W, Thygesen K, Verheugt F, Fox KM; Euro Heart Survey Investigators. Gender differences in the management and clinical outcome of stable angina. Circulation. 2006 Jan 31;113(4):490-8. doi: 10.1161/CIRCULATIONAHA.105.561647.
- Background: PubMed 8252666Murabito JM, Evans JC, Larson MG, Levy D. Prognosis after the onset of coronary heart disease. An investigation of differences in outcome between the sexes according to initial coronary disease presentation. Circulation. 1993 Dec;88(6):2548-55. doi: 10.1161/01.cir.88.6.2548.
- Background: PubMed 15650342Yawn BP, Wollan PC, Jacobsen SJ, Fryer GE, Roger VL. Identification of women's coronary heart disease and risk factors prior to first myocardial infarction. J Womens Health (Larchmt). 2004 Dec;13(10):1087-100. doi: 10.1089/jwh.2004.13.1087.
- Background: PubMed 19147625Champney KP, Frederick PD, Bueno H, Parashar S, Foody J, Merz CN, Canto JG, Lichtman JH, Vaccarino V; NRMI Investigators. The joint contribution of sex, age and type of myocardial infarction on hospital mortality following acute myocardial infarction. Heart. 2009 Jun;95(11):895-9. doi: 10.1136/hrt.2008.155804. Epub 2009 Jan 15.
- Background: PubMed 19858434Vaccarino V, Parsons L, Peterson ED, Rogers WJ, Kiefe CI, Canto J. Sex differences in mortality after acute myocardial infarction: changes from 1994 to 2006. Arch Intern Med. 2009 Oct 26;169(19):1767-74. doi: 10.1001/archinternmed.2009.332.
- Background: PubMed 11527625MacIntyre K, Stewart S, Capewell S, Chalmers JW, Pell JP, Boyd J, Finlayson A, Redpath A, Gilmour H, McMurray JJ. Gender and survival: a population-based study of 201,114 men and women following a first acute myocardial infarction. J Am Coll Cardiol. 2001 Sep;38(3):729-35. doi: 10.1016/s0735-1097(01)01465-6.
- Derived from this study: PubMed 26330414George J, Rapsomaniki E, Pujades-Rodriguez M, Shah AD, Denaxas S, Herrett E, Smeeth L, Timmis A, Hemingway H. How Does Cardiovascular Disease First Present in Women and Men? Incidence of 12 Cardiovascular Diseases in a Contemporary Cohort of 1,937,360 People. Circulation. 2015 Oct 6;132(14):1320-8. doi: 10.1161/CIRCULATIONAHA.114.013797. Epub 2015 Sep 1.
- Derived from this study: PubMed 24881994Rapsomaniki E, Timmis A, George J, Pujades-Rodriguez M, Shah AD, Denaxas S, White IR, Caulfield MJ, Deanfield JE, Smeeth L, Williams B, Hingorani A, Hemingway H. Blood pressure and incidence of twelve cardiovascular diseases: lifetime risks, healthy life-years lost, and age-specific associations in 1.25 million people. Lancet. 2014 May 31;383(9932):1899-911. doi: 10.1016/S0140-6736(14)60685-1.
- CArdiovascular disease research Linking Bespoke studies and Electronic RecordsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Permissions to used anonymised linked data from data owners prohibit further sharing of the data
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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.
Julie George, MSc principal investigator
University College, London
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease and Cardiovascular Disease, 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 1 inclusion and 3 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 12 May 2016. 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?
coronary mortality (ICD 10 I20-I25) (time frame: up to 15 years from entry into cohort). 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 NCT01164371, which also lists 12 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 12 May 2016.