CAPACITY BUILDING

Interdisciplinary Research TrainingInterdisciplinary research training: NCD epidemiology and prevention in India: The interdisciplinary training program on non-communicable diseases (NCDs) focuses on the epidemiology and prevention of NCDs across the life-course, in cross-connecting subject areas (child health, nutrition and lifestyle, environmental health, obesity and diabetes, stroke and other vascular diseases) and population science disciplines (epidemiology and biostatistics, clinical trials, translation research, social sciences, and economics). The aim of this project is to provide short-term training in year one where eight junior faculty researchers will receive four months of training at Emory to acquire specific and focused mentoring and research skills. A total of ten post-doctoral fellows (one batch of five in years 2-3 and one batch in years 4-5) will receive 24 months of training (four months at Emory in the first year, six weeks at Emory in the second year, and the remaining 18.5 months in India).

DEMONSTRATION PROJECTS

NCD EpidemiologyPrevention of type 2 diabetes in women with gestational diabetes in urban India – a feasibility study: Gestational diabetes (GDM) is a strong risk factor for developing type 2 diabetes mellitus. GDM and type 2 diabetes are both common among Indian women. Limited information about lifestyle programs to prevent or delay diabetes in women with GDM is available from other countries, but their applicability in India is unknown. We are evaluating the feasibility of adapting such programs by making them culturally appropriate to the Indian context and testing them in a small group of patients. The study is being carried out at All India Institute of Medical Sciences and the Centre for Fertility Management, Hyderabad with the aim of recruiting a total of 250 pregnant women with gestational diabetes. The results from this study will allow us to refine the program and perform a larger study to conclusively determine its generalizability and sustainability in urban India.
Funding Agency: International Diabetes Federation.

OBSERVATIONAL STUDIES

Interdisciplinary Research Training And NCD EpidemiologyThe CARRS – Surveillance Study: CCDC, the scientific and executive secretariat of the Center of Excellence in Cardio-metabolic Risk Reduction in South Asia (CoE-CARRS) in PHFI, is implementing a cohort modeled cardio metabolic surveillance study in three major cities in South Asia (Chennai, Delhi and Karachi). The study partners are PHFI, Emory University, AIIMS, Aga Khan University Karachi and Madras Diabetic Research Foundation, Chennai. The CARRS Surveillance study starts with a baseline cross-sectional survey enrolling 12,000 participants and following them over a period of three years to collect preliminary incidence, morbidity, and mortality data.
CARRS – Sub-Studies

NCD Epidemiology And Interdisciplinary Research Training1. Assessment of dietary salt intake levels among adults in Delhi and Haryana: Multiple epidemiological studies conducted worldwide have found excess dietary salt or sodium intake to be associated with increased risk of high blood pressure or hypertension. Also nearly half of blood pressure related CVD events occur among those without clinical hypertension, so population wide salt reduction is clearly one of the most cost-effective strategies to prevent CVD. This sub-study of CARRS Surveillance Study and the ICMR Urban-Rural Study seeks to provide contemporary data on salt consumption levels and sources of dietary salt in Delhi and Haryana, which will reflect recent dietary changes that are occurring in India.

The three main objectives are:

1) to determine the mean daily salt consumption through the collection of 24- hour urinary sodium excretion samples

2) to determine the main sources of salt in the diets using 24-hour dietary recall method and

3) to assess knowledge, attitudes and behaviors with regard to salt consumption and its impact on health by a questionnaire. The total duration of the proposed project is two years and survey will include 1400 participants with roughly half each residing in urban Delhi and rural Haryana.
Funding agency: PHFI and Wellcome Trust-UK Universities Consortium

2. Prevalence of Polycystic ovarian syndrome (PCOS) and its association with cardiometabolic risk factors in reproductive age women in Delhi and Chennai, India: Women with PCOS are more likely to have increased cardiometabolic risk factors. The prevalence of PCOS in India and its association with cardiometabolic risk factors have not been studied extensively. The objective of this study was to measure the prevalence of oligomenorrhea and self-reported hirsutism as markers of PCOS in a representative sample of reproductive age women in Delhi and Chennai in the CARRS (Centre for Cardiometabolic Risk Reduction) cohort. CARRS is a multi-stage cluster random sampling cross sectional survey of adults aged >20 years (non-pregnant women) to measure prevalence of cardiometabolic risk factors in South Asia. Female participants of reproductive age received an additional validated PCOS questionnaire. Our definition of PCOS is limited to oligomenorrhea and clinical features of hyperandrogenism.

To assess for oligomenorrhea, participants were asked:

1) How many menstrual cycle have you had?

2) How long was the longest menstrual cycle in the last year? (after excluding for breast feeding, menopause and hysterectomy). To assess hirsutism, women were asked to score themselves using pictures of the 9 body parts used to calculate the modified Ferriman-Gallway score.

The preliminary results from this study were presented at the American Diabetes Association Conference, San Francisco, 2014. In summary, PCOS questionnaire was administered to 1927 female participants in Delhi and Chennai. The prevalence of oligomenorrhea and hirsutism was 11.6% and 6.6%, respectively. The prevalence of oligomenorrhea and self-reported hirsutism was higher in South Asian women compared to other ethnicities. This may have implications for future cardiovascular risk in the population studied.
Funding Agency: Fogarty International Centre

3. Psychiatric determinants of cardiovascular disease: This mental health project is collaboration between CCDC and the University of Southampton and was initiated in October 2011. The propose of the project, which is part of the on-going CARRS surveillance study, is to examine the prevalence of co-morbid Axis I psychiatric disorders including alcohol use disorders and tobacco consumption, and suicide risks among 1500 community residents with cardiovascular diseases and their risk factors. Funding Agency: PHFI and Wellcome Trust

4. Personality traits, personality disorders and alcohol relapse in urban India: This study is collaboration between CCDC, NIMHANS, Bangalore and Washington University in St. Louis, USA. The study uses a longitudinal design to study personality factors of 200 participants incorporating both, self and informant reports in relation to alcohol relapse in a hospital based setting.
Funding Agency: Fogarty International Center

5. Personal social network and CVD risk behaviour in urban Delhi. Psychiatric determinants of CVD: This mental health project is collaboration between CCDC and the University of Southampton and was initiated in October 2011. The propose of the project, which is part of the ongoing CARRS surveillance study, is to examine the prevalence of co-morbid Axis I psychiatric disorders including alcohol use disorders and tobacco consumption, and suicide risks among 1500 community residents with cardiovascular diseases and their risk factors.
Funding Agency: PHFI and Wellcome Trust Personality traits, personality disorders and alcohol relapse in urban India.

6. Stress, distress and diabetes in Delhi- a qualitative study of chronic diseases in urban India: This study is collaboration between Emory University Atlanta, and CCDC. It is an ethnographic project which used in-depth interviews, embedded as a sub-study in the on-going CARRS surveillance study to examine the subjective experience of depression, stressors and coping with diabetes in Delhi.
Funding Agency: Fogarty International Centre

Prevalence of coronary heart disease (CHD) and its risk factors in residents of urban and rural areas of NCR – a repeat survey (urban component): This study aims to measure the prevalence of Coronary Heart Disease (CHD) and the pattern of distribution of selected coronary risk factors among rural and urban populations in the national capital region (NCR). This repeat survey is being done after 15 years, following the first survey in 1994 in the same population, to assess the secular changes in the prevalence of CHD and its risk factors in NCR. Adults in the age group above 30 years in rural and urban area are being assessed for CHD (using modified Rose Questionnaire & ECG) and its risk factors including tobacco use, alcohol, diet, physical activity, anthropometry and biochemical risk factors. Those testing positive for CHD by history or ECG will undergo a treadmill test. The results of this study are expected to be published by mid 2013.
Funding Agency: Indian Council of Medical Research (ICMR)

DEMAT : Detection and Management of Coronary Heart Disease patients (DEMAT) in India. This is a nationwide disease registry for acute coronary syndromes in India. The DEMAT program was designed in year 2006 with an objective to understand the prevailing practice patterns in the management of Coronary Heart Disease patients. It also envisions to help physicians identify in-hospital trends of interventional procedures (PCI, stent, CABG, etc.), and assess therapy as aggressive versus conventional management. DEMAT would help in relating the practice patterns and compliance to treatment, obtain an estimate of six months mortality, identify lacunae and develop evidence based guidelines for management. CCDC is responsible for coordination of research activities, monitoring of data collection process, source data verification, data management and data analysis of the study. Funded by MSD pharmaceuticals

Establishment of Sentinel Surveillance System for Cardiovascular Diseases in Indian Industrial Population: The first phase of the project involved the establishment of morbidity and mortality surveillance system and the conduct of a survey of cardiovascular disease, diabetes and other risk factors in ten different sites in India. The second phase involves the evaluation of a health promotion programme in these industries. This study has the endorsement of World Health organization and Ministry of Health, Government of India. CCDC is responsible for coordination, data collection, data management and data analysis of the study. CCDC has received a total grant of nearly USD 0.24 million for this project from 2002-2008. Two of the three phases including collection of baseline data, health promotion and health care interventions are over. Surveillance for mortality and morbidity due to cardiovascular diseases is currently being undertaken
Funding agency: WHO

South Delhi Initiative Project – This is a Chronic disease detection and prevention programme for Malviya Nagar Residents, New Delhi. This is again a vascular risk reduction programme at the community level. CCDC was responsible for coordination of research activities, data collection, data management and data analysis of the study.
Funding agency WHO

Comprehensive Cardiovascular Risk Reduction Programme (CCRRP) at National Thermal Power Corporation, Delhi: This is a quasi experimental demonstration project to assess the impact of a comprehensive cardiovascular risk reduction package. The package is implemented as a well being programme for employees (2500 employees) working in a large public sector unit in Delhi and their family members. CCDC is responsible for coordination of research activities, data collection, data management and data analysis of the study.
Funding agency: IC Health and NTPC

India Health Study : It is a feasibility study for a prospective cohort in Delhi, India. It involves evaluation of conducting chronic disease and diet research in India and detailed characterization of the Indian Diet, particularly with relevance to cancer; and evaluation of follow-up. The study also aims to evaluate likelihood of cancers and other chronic diseases, assessing movement pattern and traceability of Indian population and understand methods of case ascertainment. CCDC is responsible for the coordination of research activities, conduct of the feasibility assessment, data collection and data compilation. Since 2006 CCDC has received nearly USD 0.12 million towards this project Funding agency: NIH

Indian Migrants Study : It is a sib comparison, within country migration study to understand the impact of migration on cardiovascular disease risk factors in India. CCDC is responsible for coordination of research activities, monitoring of data collection process, source data verification, and data management of the study. This is being conducted in collaboration with Bristol University, UK. The scientific aim of the study is to elucidate the effects of within-country migration on obesity and diabetes mellitus in India. The main hypothesis to be considered is that risks of developing obesity and diabetes among migrants from rural to urban areas are due to differential migration conditions and subsequent social and economic changes that mediate changes in dietary intake and physical activity patterns. Since 2004, CCDC has received a grant of nearly USD 0.80 million towards the cost of this project.
Funded by Wellcome Trust

Rural Andhra Pradesh Cardiovascular Prevention Study – CCDC is working in collaboration with Byrraju Foundation to provide technical assistance for the project on Primary Health Care in Rural Andhra Pradesh. A surveillance to analyze the causes of death using verbal autopsy is currently underway in rural Andhra Pradesh since 2003. This survey formed the baseline for RAPCAPS (Rural Andhra Pradesh Cardiovascular Prevention Study). Cardiovascular disease prevention program is being undertaken as the next phase of the project.
Funded by George Institute for International Health, Sydney

CLINICAL TRIALS & TRANSLATIONAL RESEARCH

Simplified Cardiovascular Management Study (SIMCARD): The simplified cardiovascular management program, also known as the SimCard study, was a one-year cluster-randomized controlled trial carried out in 47 villages in Haryana, India and Tibet, China and with limited access to basic cardiovascular disease (CVD) management and appropriate medications. The study was carried out by the Public Health Foundation of India (PHFI) in collaboration with the Centre for Chronic Disease Control (CCDC), All India Institute of Medical Sciences (AIIMS) in India and The George Institute for Global Health at Peking University Health Science Center in collaboration with Tibet University in China.
The study enrolled 2086 individuals with high CVD risks, defined as over 40 years old with a self-reported history of CVD and a measured systolic blood pressure over 160mmHg. Community health workers (CHWs) were deployed and trained to manage those individuals with the assistance of an Android smartphone app consisting of a guideline-based but simplified CVD management program.

A simplified ‘2+2’ intervention model, which consisted of two medications (blood pressure lowering agents and aspirin) and two lifestyle modifications (smoking cessation and salt reduction), was developed. The model was based on the international and national clinical guidelines for CVD management so that it can be easily implemented and incorporated into the existing local healthcare system as well. In both China and India, interventions were tailored to the local cultures and customs when possible. For example, Health educational materials on lifestyle in China and India were all provided in local languages with cultural-specific images.
The combined results strongly demonstrated the effectiveness of the SIMCARD trial in increasing the adherence to anti-hypertensive medications, (a net-difference of 25.5%. between the control and Intervention groups) In Separate country-specific analysis, the net increase in the proportion of high-risk individuals taking aspirin was higher in China (24.5%) than in India (9.8%), but both were highly significant. There was a significant net reduction in mean SBP in China (-4.1 mmHg, P=0.006) but a non-significant decline in India. Both countries had large net increases (>16%) in the proportion of high-risk patients receiving monthly follow-up.

Use of a Multidrug Pill in reducing cardiovascular Events (UMPIRE) Trial: UMPIRE Trial is a phase 3 – randomised, controlled clinical trial of fixed-dose combination medication, Red Heart Pill, in patients (1000 in Europe and 1000 in India) at high risk of cardiovascular disease. The Red Heart Pill contains low dose aspirin, statin and two blood pressure lowering medicines and will be compared to usual cardiovascular medications to test its effect on adherence and change in blood pressure and LDL cholesterol at 12 months. The trial has completed recruiting 1000 patients each in India and Europe by July 2011; end of study visits have begun and are expected to be complete by July 2012. The Imperial College London is the International Coordinating Center while in India the study is coordinated by George Institute India, Hyderabad and CCDC, New Delhi.
Funding Agency: European Commission

STICH trial : The STICH trial was a multicentric trial conducted at 170 sites in North America, Australia, New Zealand, Europe, South America, and several countries of Asia, and Israel. A total of 2,245 patients were recruited from all over the world. A total of 300 patients were recruited from ten different sites in India. CCDC in collaboration with Duke Clinical Research Institute was responsible for establishing a network of investigators in India. It also coordinated the project at the national level.
Funding Agency: NIH

Quality Improvement Initiative in Management of Acute Coronary Syndromes: Costs and Outcomes of an Intervention to Train and Supply a non-Tertiary Care Facility for Risk Stratification, Initial Treatment, and Referral of Acute Coronary Syndromes in India was conducted. CCDC was the nodal agency responsible for smooth functioning of the project.
Funded by IC Health and WHO

ADVANCE Trial : It is an international, multi centric, factorial, randomized trial of blood pressure lowering and intensive glucose control for the prevention of vascular disease among high risk patients with Type 2 diabetes. International coordination is provided by the George Institute for International Health in Sydney, Australia with central data management provided by the clinical trials research unit in Auckland, New Zealand. The study aims to assess the effects of routine administration of ACE inhibitor- diuretic combination on serious vascular events in patients with diabetes. This trial is being done by 215 collaborating centres in 20 countries. CCDC is responsible for the national coordination of this project. . Between 2002 to 2008 CCDC has received nearly USD 0.90 million, which includes payment to the four study centers and payment to the coordinating centre.
Funding Agency: George Institute for International Health, Sydney, Australia)

Zyban – An Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome – The ZESCA Trial : The trial aims to examine the smoking abstinence rates at one-year following an enzyme positive Acute Coronary Syndrome. This is a phase IV multi-country trial which was initiated in December 2005 and is proposed to enroll 1500 patients by December 2010. Countries involved are United States, Bangladesh, Canada, India, Ireland and Tunisia. The study is being run by Jewish General Hospital/McGill University (Montreal, Quebec), Canadian Institute of Health Research (CIHR), Heart and Stroke Foundation of Ontario. In India trial is being run at the All India Institute of Medical Sciences, New Delhi.

Omega – 3 Supplementation Trial : Effect of Omega -3 fatty acids supplements and plant sterol enriched drink/food on the composite risk profile of dyslipidemic adults was studied. It was a randomized, double-blind, placebo-controlled trial with 2×2 factorial design. We had randomised 172 dyslipidemic adults in the follow up visits have been completed. CCDC was responsible for the coordination and conducting the trial. Data management and data analysis of the study was also taken up by CCDC.
Funding Agency: Hindustan Lever Ltd