Coronary Mortality in South Asians: Aetiologic and Prognostic Effects

NCT ID: NCT01163513

Last Updated: 2011-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-12-31

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

White population

No interventions assigned to this group

Indian

No interventions assigned to this group

Pakistani

No interventions assigned to this group

Bangladeshi

No interventions assigned to this group

Other

other South Asian

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. 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

2. 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

3. A coronary angiography cohort of consecutive patients undergoing elective angiography at three centres in London between 1996-1997

4. 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.

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.

Exclusion Criteria

admitted to hospital with fewer than 25 admissions in given year

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barts & The London NHS Trust

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

University College, London

Locations

Clinical Epidemiology Group, Department of Epidemiology & Public Health, UCL

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 23406688 (View on PubMed)

Other Identifiers

CALIBER 09-01

Identifier Type: -

Identifier Source: org_study_id