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Local data is very much important for latest treatment and research for any branch of ModernMedical Science

Cardiological Society of India (CSI)has always conducted and encouraged research works in the field of cardiovascular diseases for advancement of knowledge. In consonance with that tradition West Bengal chapter of CSI has also contributed to the field of research. In that endeavour the latest research project on” Epidemiological Assessment of the prevalence of standard risk factors for cardiovascular atherosclerotic disease across West Bengal “ is being launched under the able Principal Investigator Dr Debabrata Roy.


A survey will be done in different classes of people for this research across the West Bengal. The state has been divided into five geographical regions for this purpose.  These are:  Gangatic Bengal, Himalayan region, North Bengal Plain, Rarh Bangla and Mallabhum region. The main objective of this research project is to find out the prevalence of risk factors in different parts of West Bengal to frame scientific guidelines of combating and preventing the menace of escalating Coronary Artery Disease in West Bengal.

DR. P. S. Banerjee, DR. P, K, Deb, DR. M. K. Das, DR. Monoranjan Mandal, DR. Debbrata Roy, DR. Bhabani Prasad Chatterjee & DR. Dilip Kumar has been meet the press along with  many otherinterventional cardiologists of the city.

The synopsis of the project has been enclosed for detail study.

Introduction

The purpose of this study is to assess the prevalence of common cardiovascular disease and associated risk factors in the state of West Bengal with regional granularity. The rapid socio-economic progress in India has had a great impact on the lifestyle of the population. With the acceleration in urbanization, industrialization, aging and lifestyle changes, the prevalence of cardiovascular disease (CVD) in India has dramatically increased and will remain on an upward trend in the next decades. Cardiovascular disease generally refers to conditions that involve narrowed or blocked blood vessels, and those that affect the heart’s muscle, valves or rhythm, leading to heart attack, chest pain or stroke. The increasing disease burden of CVD has become a major public health issue. The ongoing deterioration in cardiovascular risk factors (CRFs) appears to be the major cause of inducing the CVD epidemic in India. The risk of various forms of heart disease generally increases with age, with men being at a greater risk than women. Genetic factors most commonly result in greater risk in individuals with a family history of a similar disease. Environmental and lifestyle factors such as smoking, poor diet, physical inactivity, poor hygiene, stress, and pollution also increase the risk. Individuals with hypertension (high blood pressure), diabetes and hyperlipidemia (especially excess cholesterol) are at exceptionally high risk of developing heart disease. It is well known that cigarette smoking, overweight or obesity, hypertension, diabetes, and dyslipidemia are five major modifiable CRFs that can be altered or eliminated through proper management. A number of studies have indicated that the prevalence of CRFs has increased in recent decades in India. Furthermore, the clustering of these risk factors in the same individual will significantly increase the risk of CVD events compared with a single risk factor. A complete assessment of the distribution and aggregate of well-established CRFs depicts the risk of developing CVD and is useful in formulating effective prevention strategies. CVD is the leading cause of mortality in West Bengal. Although there have been similar studies previously in foreign countries, there has been no large-scale study with an adequate sample size to evaluate the prevalence and clustering of CVD risk factors in West Bengal. In the present study, we performed a community-based survey to estimate the up-to-date prevalence and clustering of CVD risk factors, and investigate the association between relevant characteristics and CVD risk factor clustering among a large representative sample of the West Bengal adult population from eastern India.

Methods

Study Population

No special populations are targeted for accrual to this study. However, ethnic background may play a role in disease prevalence, and a variety of ethnic groups is optimal for this study to address that question. Thus, the patient’s self-reported ethnicity information will be included with the sample. Participants will be recruited based on a door to door survey where the purpose of the study will be explained in the local language and a subsequent interview would capture demographic details of the individuals. A computer-selected random list will then be prepared for invitations and the invitations will be communicated to the selected individuals along with the date, location, and duration of the camp. The study will not exclude potential subjects from participation on the basis of ethnic origin or gender. Subjects recruited will include men, women, and all ethnic origins, provided they meet all eligibility criteria as follows:

A. Age: Participants’ age must be no less than 18 years and no more than 65
B. Family members: No more than one male and one female member of a family would be recruited

The study would consist of identification of camp locations across the state of West Bengal. Participants will be recruited based on representative demographic sample selection following a door to door survey in the neighborhood of the camp locations. The state of West Bengal is to be divided into geographically distinct regions:

1. Darjeeling Himalayan Hills: population 2.1 million, comprising the district of Darjeeling and Kalimpong
2. Terai/Dooars: population 6.7 million, comprising the districts of Jalpaiguri, Alipurduar, and Cooch Behar
3. North Bengal Plains: population 8.7 million, comprising the districts of Uttar Dinajpur, Dakshin Dinajpur, and Malda
4. Rarh: population 13.5 million, comprising the districts of Murshidabad, Birbhum, and Paschim Bardhaman
5. Western Plateau: population 18.6 million, comprising the districts of Purulia, Bankura, Jhargram, Paschim Medinipur, Purba Medinipur
6. Ganges Delta: population 43.1 million, comprising the districts of Nadia, Purba Bardhaman, Hooghly, Howrah,  Kolkata, North 24 Parganas, and South 24 Parganas

Within each region, the rural and urban population would be studied separately. The proposed number of camps per region, based on the target population, the size of the region and the number of urban centers, are listed in Table 1.

Region

Urban Camps

Rural Camps

Darjeeling Himalayan Hills

1

1

Terai/Dooars

1

2

North Bengal Plains

1

2

Rarh

2

2

Western Plateau

2

2

Ganges Delta

3

3

Table 1: Proposed number of urban and rural camps per region.

Each camp would have approximately 150 participants with a representative coverage of gender, age group, and economic status. Based on such prior information, we will construct the sample population needs, to estimate each prevalence percentage with a 95% credible interval and a 1% accuracy bound across the whole state. Variation of prevalence across regions, gender, and age-groups would be computed at 5% accuracy levels with a 95% credible environment.

Data Collection and Management

A door to door survey will be conducted in the neighborhood of the camp location, seeking to invite a representative population of participants. The survey would include a questionnaire filled out by the purveyors based on interviews. The questionnaire will capture the participant’s demographic and contact information. Once the enrollment information is filled in, the interviewer would determine if the inclusion criteria are met. Participants will be bucketed according to gender, age group and economic status and invitations will be randomly generated in proportion to the sub-populations reported in census data. Exclusions will focus on reducing the number of close relatives, to ensure genetic variation. Subjects would be enrolled in the study by invitation, based on a door to door survey. Each subject enrolled in the study would be interviewed based on a structured questionnaire, following which they would undergo physical measurements and spot tests.    Physical measurements will include weight, height and blood pressure (BP). Weight will be measured with light clothing to the nearest 0.1 kg and height will be measured without shoes to the nearest 0.1 cm. Body mass index (BMI) will be calculated as weight in kilograms divided by the square of the height in meters. Participants would be advised to avoid smoking cigarettes, drinking alcohol, taking tea or coffee or engaging in PA for at least 30 min before BP measurements.  Finally, blood samples will be collected from all subjects for laboratory analysis. Laboratory examinations will include blood glucose and four items of blood lipids. The laboratory will complete the blood examinations within 8 hours of receiving the samples. Blood glucose will be measured enzymatically using a glucose oxidase method. Serum lipids, including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C) will be measured.

Assessment Criteria

Cardiovascular Risk Factors

Five major CVD risk factors are defined based on current national guidelines. Hypertension will be defined as self-reported current treatment with antihypertensive medication in the past 2 weeks, and/or an average systolic BP (SBP) ≥140mm Hg and/or an average diastolic BP (DBP) ≥90mm Hg.

The categorization of our study population will be based on their results compared to the following table of reference ranges

Median and average CV for biochemical parameters

Parameters

Median (25–75th percentile)

CV %

Fasting glucose (mg/dL)

93 (87–100)

7.8

2 h post glucose (mg/dL)

104 (97–116)

14.5

T. cholesterol (mg/dL)

183 (159–210)

17.5

HDL (mg/dL)

48 (42–55)

13.0

LDL (mg/dL)

110 (91–130)

16.2

TGL (mg/dL)

(88–168)

28.2

Hemoglobin A1C

< 6.5%

Reference:

Shrilekha Sairam et. al, “Hematological and Biochemical Parameters in Apparently Healthy Indian Population: Defining Reference Intervals”, Indian Journal of Clinical Biochemistry (2013), DOI: 10.1007/s12291-013-0365-5

Manisha Nair et. al, “HbA1c Values for Defining Diabetes and Impaired Fasting Glucose in Asian Indians”, Prim. Care Diabetes (2011), DOI: 10.1016/j.pcd.2011.02.002

Covariates

Occupation, income and education will be taken into the assessment of socioeconomic status (SES). The occupation will be recorded into four groups: manual laborers, service staff, mental laborers and others (unemployed and retired people). The total annual family income will be divided into tertiles: lower, middle and higher. Education will be grouped into three categories: primary school and lower, junior or senior high school, and college and higher. A semi-quantitative Food Frequency Questionnaire (FFQ) will be used to assess dietary intake during the previous year.

Quality Control

In order to ensure the reliability of the investigation data, vigorous quality control will be implemented by our quality control team. The quality control will be conducted throughout the survey period, including design and revision of the preliminary plan, unifying investigation tools, preparing standard training materials and technical requirements, conducting field supervision and technical guidance, extracting 10% questionnaire for verification and 5% respondents to review their physical measurements at each surveillance points, and data cleaning and analysis. The coincidence rate will be over 95%. The feedback and corrections will be made timely when the problems were found. All study investigators completed a uniform training program and passed the examination at the end of the training. A manual of procedures will be distributed by our team, and detailed instructions for administration of the questionnaires, anthropometric measurements, and biological specimen collection were provided.

Statistical Analysis

Modern statistical analysis is to be used to inform every step of the study design, from population and sample selection to extracting relevant information from the data. We will be using a Bayesian process to estimate the population requirements for our study. We begin with earlier studies that have estimated the prevalence of hypertension and other cardiovascular diseases in India. Based on such prior information, we construct the sample population needs to estimate each prevalence percentage with a 95% credible interval and a 1% accuracy bound across the whole state. Variation of prevalence across regions, gender, and age-groups would be computed at 5% accuracy levels with a 95% credible environment. Co-occurrence will be estimated using conditional probabilities with estimators being tested for statistical credibility. Prior to such computations, factors will be tested for dependence and, if found, principal components will be constructed to eliminate confounding.

Patient Involvement

Patients were not involved in setting the research question, the outcome measures, the design or the implementation of the study. No patients will be asked to advise on interpretation or writing up of results. No patients will be advised on the dissemination of the present study and its main results. Patient influence on the study is limited to subjective answers to the self-reporting of symptoms and conditions.

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