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  1. Definition of terms
 
Acute Coronary syndrome (ACS) refers to a constellation of clinical signs and symptoms produced by acute myocardial ischemia.  It comprises unstable angina (UA) and acute myocardial infarction (AMI) associated with ST-segment elevation or depression.  The majority of patients with ST-segment elevation ultimately develop a Q-wave AMI (QMI), whereas a minority develops a non Q-wave AMI ( NQMI).  Patients with angina and no ST-segment elevation have either UA or non ST-segment elevation myocardial infarction (NSTEMI).  The two conditions can be differentiated by the presence or absence of the circulating markers of myocyte necrosis.  Most patients with NSTEMI do not evolve a Q wave on the 12 lead electrocardiogram (ECG) and are subsequently referred to as having sustained a NQMI; only a minority of NSTEMI patients develop a Q wave and are later diagnosed as having QMI.  The spectrum of clinical conditions that range from UA to NQMI and QMI is referred to as ACS.

In the present guidelines, UA and NSTEMI are considered to be closely related conditions whose pathogenesis and clinical presentations are similar but of differing severity; that is, they differ primarily in whether the ischemia is severe enough to cause sufficient myocardial damage to release detectable quantities of a marker of myocardial injury, most commonly troponin I (TnI), troponin T (TnT), or creatinine kinase – MB (CK-MB).  Once it has been established that no biochemical marker of myocardial necrosis has been released, the patient with ACS may be considered to have experienced UA, whereas the diagnosis of NSTEMI is established if a marker has been released.  In the latter condition, ECG ST-segment or T-wave changes may be persistent, whereas they may or may not occur in patients with UA, and if they do, they are usually transient.
2. Background information and Rationale
Coronary artery disease as assumed epidemic proportion in India.  Over 80% of deaths and 85% of disability from cardiovascular disease (CVD) occur in low- and middle-income countries. The Indian subcontinent is home to 20% of the world’s population and may be one of the regions with the highest burden of CVD in the world.

The absence of reliable mortality data in the Indian subcontinent has necessitate estimates of the CVD burden based on cross-sectional studies that have been well described previously.  In 2003, the prevalence of CHD in India was estimated to be 3-4% in rural areas and 8-10% in urban areas with a total of 29.8 million affected according to population-based cross-sectional surveys.  The estimate is comparable to the figure of 31.8 million affected, derived from extrapolations of the Global Burden of Diseases study.  However, these numbers are still likely underestimates as they do not account for those with silent myocardial infarction or otherwise asymptomatic CHD.

In 1990 there were an estimated 1.17 million deaths from CHD in India, and the number is expected to almost double to 2.03 million by 2010. In addition to the high rate of CHD mortality in the Indian subcontinent, CHD manifests almost 10 years earlier on average in this region compared with the rest of the world resulting in a substantial number of CHD deaths occurring in the working age group. 

In Western countries where CVD is considered a disease of the aged 23% of CVD deaths occur below the age of 70; this compares with 52% of CVD deaths occurring among people under 70 years of age in India.  As a result, the Indian subcontinent suffers from a tremendous loss of productive working years due to CVD deaths: an estimated 9.2 million productive years of life were lost in India in 2000, with an expected increase to 17.9 million years in 2030.  The health and economic implications of this staggering rise in early CVD deaths in South Asian countries are profound and warrant prompt attention from governing bodies and policy makers of these countries.   The huge burden of CVD in the Indian subcontinent is the consequence of the large population and the high prevalence of CVD risk factors.

Urbanization is characterized by a marked increase in the intake of energy-dense foods, a decrease in physical activity, and a heightened level of psychosocial stress, all of which promote the development of dysglycemia, hypertension, and dyslipidemia.

The Indian subcontinent has a higher prevalence of diabetes mellitus than any other region in the world, and 2-3 times the reported prevalence in Western countries.  In India alone, an estimated 19.3 million people had diabetes in 1995, and this is expected to almost triple to 57.2 million in 2025.  The Indian Council of Medical Research estimates that the prevalence of diabetes is 3.8% in rural areas, compared with 11.8% in urban areas.

Hypertension is even more prevalent (20-40% among urban and 12-17% among rural adults, affecting an estimated 118 million inhabitant in India in 2000. 

In 2002, a national survey of tobacco use reported that the Indian subcontinent, second only to China in both the production and consumption of tobacco products, had an alarming rate of current tobacco use of 56% among Indian men age 12-60 years. New Wave of smoking among India’s youth that forebodes serious future public health consequences for the Indian subcontinent.

The Indian Council of Medical Research (ICMR) surveillance project reported a prevalence of dyslipidemia (defined as a ratio of total to HDL cholesterol > 45) of 37.5% among adults aged 15-64 years, with an even higher prevalence of dyslipidemia (62%) among young male industrial workers.

Kerala Scenario
The last 30 years has seen a remarkable transition in Kerala. The state is supposed to be in the Stage III of the epidemiologic transition.  Cardiovascular death is 50% of the total death and by 2020 it is predicted to go up to 2/3 of the total death. Kerala has the highest life expectancy, the lowest infant mortality rate, and maternal mortality rate.  This  social transition also has unfortunately led to the highest prevalence of Coronary Artery Disease among all Indian states with a rural prevalence of 7.5% and urban prevalence of 12%. This is more than the so-called North Indian – South Indian divide in prevalence. Even the urban, rural divide seen all over India is not so manifest in Kerala.  It is said that Kerala has no villages. In a single medical college hospital in Kerala there has been a more than 20-fold increase in admissions for acute MI from 1966 to 1988.  Number of acute MI cases was 220 / 22387 in 1967, which increased to 440/23410 in 1970, 1500 / 33134 in 1975,  4901/43937 in 1982 and 5284 / 43897 in 1987.

The epidemic of Coronary Artery disease in Kerala warrants an urgent actions in terms of expanding public education, control of primordial & primary risk factors by population based and high-risk interventions & other effective preventive strategies. 

It is clear that the population of Kerala is at very high risk of death from cardiovascular disease.  Extrapolating the Varkala ICDS Block data it can be surmised that at least 38,000 people die of heart attack in Kerala every year.  Otherwise everyday about 110 people die of heart attack somewhere in Kerala.  One may also conjuncture that 1.5 lakhs people develop heart attacks in Kerala every year.

This is not surprising when one understands the preponderance of risk factor of cardiovascular disease in Kerala.  The ICMR / WHO study on Non communicative disease risk factors estimate there are 8.72 million hypertensives in Kerala.  The estimated number of diabetic are an astounding figure of 3.48 million. 52.1% of males and 61.4% of female populations has a total cholesterol of > 200 mg/dl.

80% of the heart attacks can be prevented by appropriate management and prevention strategies. Overall there is no programme for the Control of chronic disease in India or Kerala, possibly because of the greater focus of the health systems on infectious disease and maternal & child health.

Cardiological Society of India Kerala chapter has decided to begin a major preventive Cardiology initiative, which is aimed at not only primary prevention but also reducing the coronary risk factors in the populations.  Setting up of Acute Coronary Syndrome registry by the CSI Kerala Chapter is one such initiative. Registries and surveys can collect data rapidly and efficiently, allowing an analysis of a disease condition over particular chronological interval.  Registry and survey data allow clinicians to compare the own practice with that of larger national or international reference populations.  This provides an important stimulating for improvements in quality and consistency of practice. Registries can provide morbidity and mortality analysis risk prediction, and resource utilization calculations particular disease entities.

Primary Objectives: 
To know the pattern of presentation of Coronary Artery Disease in Kerala.
To Asses the risk factor profile.
To understand the practice pattern of management.
To estimate the 30 day event rate ( Death / Revascularization ).

Study / Program Design / Methodology:

To Study patients admitted with Acute Coronary Syndrome in possibly every Non Tertiary & Tertiary Hospitals in Kerala State.
Data Collections : All relevant data is collected through well developed questioners.  The standardized questioners will be administrated by trained coordinators.

The Information include :
Demographic variables such as Age , Sex, Education level, occupation etc
Economic status
Medical history before hospitalization, CAD & risk factor history, Previous major interventions and previous medications
Current clinical information, onset information, physical examination, laboratory investigations as ECG & Cardiac
enzymes, blood sugar, lipid profile etc.  Medication during hospitalization.
Major In hospital events / Procedures
Medication at discharge
30 day Events ( death or Revascularization )

Proposed plans of analyses
All data will be stored electronically.  Names will not be entered on the computer database where information will be held on each subject using a unique identification. Analysis will include quantitative and qualitative analyses by proper statistics methods.

Expected outcome
The study will provide insight into the pattern of presentation of CAD in Kerala, demographic and medical characteristics of patients, contemporary practice patterns in the management of Acute Coronary Syndrome and Clinical outcomes for patients.

Time Frame


Key References
The world Health Report 1999: The double burden: Emerging epidemics and persistent problems. WHO 1999.
Murray CJL, Lopex AD. Mortality by cause for eight regions of the world : Global Burden of disease Study.  Lancet. 1997;349: 1269-1276

Rajeev Gupta: Burden of Coronary Heart Disease in India : Indian Heart J 2005; 57:632-638.
Raman Kutty V, Balakrishnan K.G., Jayasree A.K., Thomas J. Prevalence of Coronary Heeart disase in the rural population of Thiruvananthapuram distric, Kerala, India. Int J Cardiol. 1993;39:59-70

Mammi MVI, Pavithran P, Rahman P.A et al. Acute M in North Kerala. A 20-year hospital based study.  Indian Heart J 1991; 43: 93-6.

V.K.Bahl, D. Prabhakaran, G. Karthikeyan. Coronary Artery Disease in Indians: Coronary Artery Disease in Indians - -  IHJ Nov-Dec 2001.mht.

Lori Mandelzweig, Alex Battler, Valentina Boyko, Hector Bueno. The Second Euro Heart Survey on acute coronary syndromes: characteristics, treatment, and outcome of patients with ACS in Europe and the Mediterranean Basin in 2004. European Heart Journal (2006) 27, 2285-2293.

Keith A. A. Fox*. Registries and Sureys in acute coronary syndrome. European Heart Journal (2006) 27, 2260-2262.

Reddy K.S., Yusuf S. Emerging epidemic of cardiovascular disease in develoing countries.  Circulation . 1998;97 : 596 - 601

Yusuf S, Reddy S, Ounpuu S, et al. Global burden of cardiovascular diseases, I: general considerations, the epidemiologic transition, risk factors, and impact of urbanization. Circulation. 2001;104: 2746-2753

K.R. Thankappan, S. Sivasankaran – Prevalence, Correlates Awareness, Treatment and control of hypertension in Kumarakom Kerala. Indian Heart Jl. 2006. 58:28-33

Pattern of Acute Coronary syndrome In India – CREATE Registry. Indian Heart Jl. 2003. 55:463
Ryan J.W, Peterson ED for CRUSADE Investigators circulation 2005. 112:3049
Yusuf S, Hawkin S on behalf of the INTERHEART Study Investigators. Lancet 2004. 304:937
Abhinav Goyal, Salim Yusuf – Burden of Cardiovascular disease in The Indian Subcontinent. Indian J. Med Res . Sept 2006. 235


   

 
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