Acute Coronary SyndromesCALIBERNCT01163513
Coronary Mortality in South Asians: Aetiologic and Prognostic Effects
An observational study of Acute Coronary Syndromes, run by University College, London at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine the extent to which South Asian ethnicity is both an etiologic and prognostic factor for coronary disease, and investigate factors influencing outcomes. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Acute Coronary Syndromes
- How many people
- 100,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to Dec 2010
- 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
- No healthy volunteers
- Adult, Older adult
Study population: ACS registry data (MINAP) - with hospital admission databases (Hospital Episode Statistics (HES)
Who may be able to join
- An aetiological healthy population study, the Whitehall II Study, comprising non-industrial civil servants aged 35-55 years who worked in the London offices of 20 civil service departments at baseline (1985-1988), will be used
- A chest pain clinic cohort of consecutive ambulatory patients with no prior investigations for coronary disease and no prior history of acute coronary syndrome recruited in six rapid access chest pain clinics from 1996-2002
- A coronary angiography cohort of consecutive patients undergoing elective angiography at three centres in London between 1996-1997
- Patients with a record in MINAP between 1 Jan 2003 - latest date available in 2009. Only index MINAP events will be included in the analysis.
- To obtain old data for meta-analysis, we will undertake a systematic review. We will search MEDLINE 1966-2008, without any language restriction, using relevant text words and search terms to find papers using the following inclusion criteria: coronary artery disease, South Asian ethnicity with White Caucasian comparison group, prospective study. We will use the MESH terms (India or Pakistan or Bangladesh or Sri Lanka or Ethnic Groups or ethnology or Asian Continental Ancestry Group or Asia) and (coronary or myocardial infarction or myocardial ischemia or cardiovascular disease). To focus further on longitudinal studies, the search will be expanded using a combination of all the Medline Clinical Queries filters for incidence and prognosis and including 'follow-up studies' and 'treatment/disease-outcome' as terms as well. The search will be repeated in Embase. Hand-searching of the reference list of eligible studies will be conducted to identify further relevant work (backward citation tracking). Science Citation Index will be used to identify all the subsequent papers that cited any of the eligible studies (forward citation tracking) using ISI Web of Science.
- We will exclude any study that covers an ethnic group other than South Asian, studies not on coronary disease and studies that examined cross-sectional mortality or cross-sectional associations of cardiovascular risk factors with populations.
Who cannot join
- admitted to hospital with fewer than 25 admissions in given year
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Epidemiology Group, Department of Epidemiology & Public Health, UCL
London, WC1E 6BT
About this study
Official title: Cardiovascular Disease Research Using Linked Bespoke Studies and Electronic Records
The purpose of this study is to determine the extent to which South Asian ethnicity is both an etiologic and prognostic factor for coronary disease, and investigate factors influencing outcomes.
Read the detailed description
Coronary death rates among first-generation migrants from South Asia are higher than those of the White majority population. Understanding the relative contribution of incidence and case fatality to overall coronary death rates allows preventive interventions to be targeted where they are likely to be more efficacious.
We seek to do this by meta-analysing new data with previously published work identified after systematic review of published literature. We will combine studies spanning different modes of presentation with coronary disease from 'normal' populations to suspected stable angina to higher-risk patients diagnosed with ACS within a national registry [MINAP].
Initially we will undertake retrospective cohort studies using four new databases (The aetiologic healthy population study, the Whitehall II Study; The chest pain clinic cohort with new-onset chest pain; the coronary angiography cohort (ACRE) and an acute coronary syndrome cohort, the Myocardial Infarction National Audit Project (MINAP).
We will define ethnicity according to the UK Office for National Statistics 1991 census categories. All four cohorts are flagged for mortality with the Office for National Statistics.
We will use a combined non-fatal outcome (non-fatal myocardial infarction and admission with angina) in the aetiologic cohort, as well as risk of coronary death. We will assess risk of coronary death in the chest pain clinic and coronary angiogram cohorts and all-cause death in the acute coronary syndrome cohort as cause-specific death is unavailable. We will assess prognosis for coronary death in Whitehall-II among those who had had typical angina at baseline. We will perform Cox proportional hazards regression adjusted for age (as a continuous variable), sex, hypertension, blood cholesterol, smoking and diabetes in all cohorts. We will then stratify these analyses in our prognostic studies by age, diabetes, ACS type, deprivation, smoking and secondary prevention management and formally examine whether a statistical difference exists between the hazard ratio of strata with the Bland-Altman two-tailed test of interaction.
We will combine results of new and older studies and calculate pooled odds ratios, weights, and 95% confidence intervals using a random effects model. Heterogeneity will be examined using the I2 statistic.
- Conditions
- Acute Coronary Syndromes
- Keywords
- ethnicity, prognosis
- Medical subject headings
- Acute Coronary Syndrome
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 |
|---|---|---|
| White population | Not described | |
| Indian | Not described | |
| Pakistani | Not described | |
| Bangladeshi | Not described | |
| Other | other South Asian |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
365 days Mortality from all causes from the date of admission
Measured: 365 days
Secondary outcomes (1)
all causes in-hospital mortality
death during duration of hospital stay
Measured: length of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startAug 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2010 (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 Acute Coronary SyndromesStudies 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
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163513
- Sponsor's protocol ID
- CALIBER 09-01
- Acronym
- CALIBER
- Status last verified
- Jul 2010
- First submitted
- 16 Apr 2010
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zaman MJ, Philipson P, Chen R, Farag A, Shipley M, Marmot MG, Timmis AD, Hemingway H. South Asians and coronary disease: is there discordance between effects on incidence and prognosis? Heart. 2013 May;99(10):729-36. doi: 10.1136/heartjnl-2012-302925. Epub 2013 Feb 13.
PubMed 23406688
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Disease Research Using Linked Bespoke Studies and Electronic Records
- ClinicalTrials.gov ID
- NCT01163513
- Acronym / sponsor ID
- CALIBER / CALIBER 09-01
- Conditions
- Acute Coronary Syndromes
- Keywords
- ethnicity, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Barts & The London NHS Trust
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 15 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 purpose of this study is to determine the extent to which South Asian ethnicity is both an etiologic and prognostic factor for coronary disease, and investigate factors influencing outcomes.
Detailed description
Coronary death rates among first-generation migrants from South Asia are higher than those of the White majority population. Understanding the relative contribution of incidence and case fatality to overall coronary death rates allows preventive interventions to be targeted where they are likely to be more efficacious.
We seek to do this by meta-analysing new data with previously published work identified after systematic review of published literature. We will combine studies spanning different modes of presentation with coronary disease from 'normal' populations to suspected stable angina to higher-risk patients diagnosed with ACS within a national registry [MINAP].
Initially we will undertake retrospective cohort studies using four new databases (The aetiologic healthy population study, the Whitehall II Study; The chest pain clinic cohort with new-onset chest pain; the coronary angiography cohort (ACRE) and an acute coronary syndrome cohort, the Myocardial Infarction National Audit Project (MINAP).
We will define ethnicity according to the UK Office for National Statistics 1991 census categories. All four cohorts are flagged for mortality with the Office for National Statistics.
We will use a combined non-fatal outcome (non-fatal myocardial infarction and admission with angina) in the aetiologic cohort, as well as risk of coronary death. We will assess risk of coronary death in the chest pain clinic and coronary angiogram cohorts and all-cause death in the acute coronary syndrome cohort as cause-specific death is unavailable. We will assess prognosis for coronary death in Whitehall-II among those who had had typical angina at baseline. We will perform Cox proportional hazards regression adjusted for age (as a continuous variable), sex, hypertension, blood cholesterol, smoking and diabetes in all cohorts. We will then stratify these analyses in our prognostic studies by age, diabetes, ACS type, deprivation, smoking and secondary prevention management and formally examine whether a statistical difference exists between the hazard ratio of strata with the Bland-Altman two-tailed test of interaction.
We will combine results of new and older studies and calculate pooled odds ratios, weights, and 95% confidence intervals using a random effects model. Heterogeneity will be examined using the I2 statistic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| White population | – | – |
| Indian | – | – |
| Pakistani | – | – |
| Bangladeshi | – | – |
| Other | – | –other South Asian |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ACS registry data (MINAP) - with hospital admission databases (Hospital Episode Statistics (HES)
Key inclusion criteria (6 listed)
- An aetiological healthy population study, the Whitehall II Study, comprising non-industrial civil servants aged 35-55 years who worked in the London offices of 20 civil service departments at baseline (1985-1988), will be used
- A chest pain clinic cohort of consecutive ambulatory patients with no prior investigations for coronary disease and no prior history of acute coronary syndrome recruited in six rapid access chest pain clinics from 1996-2002
- A coronary angiography cohort of consecutive patients undergoing elective angiography at three centres in London between 1996-1997
- Patients with a record in MINAP between 1 Jan 2003 - latest date available in 2009. Only index MINAP events will be included in the analysis.
- To obtain old data for meta-analysis, we will undertake a systematic review. We will search MEDLINE 1966-2008, without any language restriction, using relevant text words and search terms to find papers using the following inclusion criteria: coronary artery disease, South Asian ethnicity with White Caucasian comparison group, prospective study. We will use the MESH terms (India or Pakistan or Bangladesh or Sri Lanka or Ethnic Groups or ethnology or Asian Continental Ancestry Group or Asia) and (coronary or myocardial infarction or myocardial ischemia or cardiovascular disease). To focus further on longitudinal studies, the search will be expanded using a combination of all the Medline Clinical Queries filters for incidence and prognosis and including 'follow-up studies' and 'treatment/disease-outcome' as terms as well. The search will be repeated in Embase. Hand-searching of the reference list of eligible studies will be conducted to identify further relevant work (backward citation tracking). Science Citation Index will be used to identify all the subsequent papers that cited any of the eligible studies (forward citation tracking) using ISI Web of Science.
Key exclusion criteria (1 listed)
- admitted to hospital with fewer than 25 admissions in given year
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
All-cause mortality
Time frame: 365 days
365 days Mortality from all causes from the date of admission
1 secondary outcome
all causes in-hospital mortality
Time frame: length of hospital stay
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
- Derived from this study: PubMed 23406688Zaman MJ, Philipson P, Chen R, Farag A, Shipley M, Marmot MG, Timmis AD, Hemingway H. South Asians and coronary disease: is there discordance between effects on incidence and prognosis? Heart. 2013 May;99(10):729-36. doi: 10.1136/heartjnl-2012-302925. Epub 2013 Feb 13.
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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 Acute Coronary Syndromes, 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 6 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 21 Feb 2011. 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?
All-cause mortality (time frame: 365 days). 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 NCT01163513, 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 21 Feb 2011.