Title: Derivation and validation of a risk model for prediction of cardiovascular disease events in UK Indian Asians
Funder: Department of Health and Social Care

Abstract: Aims and objectives · To improve prediction of cardiovascular disease (CVD) risk amongst UK Indian Asians through development, validation, evaluation and dissemination of a risk prediction model for use in Indian Asians, based on fatal and non-fatal CVD events. · Thereby to reduce the burden of CVD in this high-risk ethnic group, redressing a major health inequality in the NHS. Background · CVD rates are ~70% higher among UK Indian Asians compared to European whites, representing a major challenge for NHS and the local health economies where minority ethnic groups are centred. · National policy mandates that all adults should be offered CVD risk assessment and receive advice and treatment to reduce their risk. The Framingham risk functions are available for risk stratification among European whites but there are no validated models for CVD risk prediction among Indian Asians. · We have completed the baseline characterisation of 22,623 Indian Asian men and women aged 35-74 years and free from clinically manifest CVD, in the London Life Sciences Prospective Population (LOLIPOP) study. Indian Asians have been recruited from the lists of 58 GPs in West London, during 2003-7. Follow-up of this cohort provides a unique opportunity for the first well-powered, prospective evaluation of the quantitative relationship between cardiovascular risk factors and incident CVD events amongst Indian Asians, and the development of a risk model that accurately predicts CVD in this high-risk population. Research plans · Identify new cases of fatal and non-fatal CVD among 22,623 UK Indian Asian men and women participating in the LOLIPOP study. · Using simple, readily available clinical measures, derive and validate models which accurately predict CVD event rates in UK Indian Asians. Select the preferred CVD risk prediction model using ROC curves, c statistics, and goodness of fit tests. · Carry out a health economic evaluation of implementing the CVD risk prediction model into clinical practice, for local and national health economies. · Undertake a qualitative study to evaluate the utility and acceptability to general practitioners and patients of introducing the model into clinical practice. · Disseminate the model for prediction of CVD in UK Indian Asians, for incorporation into guidelines and use in every day clinical practice. Research team · The research team includes national / international experts in: coronary heart disease and stroke among Indian Asians; preventative cardiovascular medicine; cardiovascular epidemiology; medical statistics; health economics; qualitative research methodology; and derivation and incorporation of risk prediction models into guidelines for implementation in clinical practice. Research environment · This research will be hosted by the new Imperial College Healthcare NHS Trust, the largest provider of healthcare in the UK, working with Imperial College London, one of the leading research-intensive universities in Europe. Anticipated outcomes, outputs and impact · This research will provide a validated CVD risk prediction model specifically tailored to UK Indian Asians, based upon CVD events. More accurate risk stratification will enable better implementation of preventive treatments, thereby reducing the burden of CVD among UK Indian Asians and addressing an important health inequality. · The research will quantify at a local and national scale, the health economic impact of implementation of the UK Indian Asian risk score into everyday clinical practice, and will evaluate the acceptability and utility of the risk prediction tool among patients and doctors. · The risk prediction models will be disseminated into guidelines for use in daily clinical practice by Q3 2012. Public involvement · The public will be directly involved in the qualitative research and will advise on development of the interview protocols, help interpret emerging findings and suggest avenues of enquiry. · The public will be involved in discussions on the formats in which the tool is made available, and advise on disseminating the risk model, and optimal approaches to engaging the support of the wider public. Ethical implications · The LOLIPOP study is approved by Ealing Hospital Research Ethics Committee. The consent form complies fully with MRC guidelines. A further submission for ethical approval will be made to undertake the follow-up and qualitative studies. Justification for resources · Most of the resource is allocated to direct pay costs of new staff to prosecute the research. The staff costs include funding for 1. clinical follow-up over the first 2 years, of 22,623 LOLIPOP cohort participants, 2. collation of source data for possible CVD events, 3. data analysis, 4. health economic and qualitative evaluations, and 5. dissemination of the risk prediction model. The remaining funding is primarily allocated to analysis of ~19,000 ECGs.

Lay abstract: Heart disease and stroke are the commonest causes of death in the UK. Indian Asians in the UK are almost twice as likely to suffer from heart attack or stroke, or to die from these diseases as the general population. This increased risk represents a major health inequality, and reducing it is an urgent priority. NHS policy states that adults should be offered an assessment of their risk of heart disease and stroke, so that they can be offered treatment to reduce their risk. Although there are useful tools for identifying European white people who are at high risk, there are no such tools for use in Indian Asians. We have previously examined 22,623 Indian Asian men and women aged 35-74 years as part of the London Life Sciences Prospective Population (“LOLIPOP”) study. In this proposal, we plan to follow-up the LOLIPOP participants to find out which of them has had a heart attack or a stroke since we first saw them. This will allow us to work out which Indian Asians are most likely to go on to get heart attack and stroke. This information will allow us to produce “risk prediction” tools for use in Indian Asians to help both doctors and patients work out who is at risk, and most likely to benefit from treatment. We will carry out an analysis of the cost and benefits of introducing our new risk prediction tools into routine clinical practice. This will include estimating how many heart attacks, strokes and deaths will be prevented as a result of the extra treatment arising from use of our tools. We will directly involve the public in the research, to help interpret findings, suggest avenues of enquiry, and to advise on the dissemination of the results. The research team includes national / international experts in heart disease and stroke, statistics, economics, and experts involved in setting treatment guidelines for doctors. The research will be hosted by the Imperial College Healthcare NHS Trust (London), the largest NHS Trust in the UK, working in collaboration with Imperial College London, one of the leading research universities in Europe.

Research activity codes: 2.4 SURVEILLANCE AND DISTRIBUTION;4.4 POPULATION SCREENING
Health categories: STROKE;CARDIOVASCULAR