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CTRI Number  CTRI/2024/05/067751 [Registered on: 21/05/2024] Trial Registered Prospectively
Last Modified On: 03/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Heart Issues in Rural Wardha: Knowing Coronary Artery Disease 
Scientific Title of Study   Assessing the Clinical Presentation of Coronary Artery Disease in Rural Population of Wardha District  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Minal Gopichand Ambilkar 
Designation  Post Graduate Student 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Clinical Research Department School of Allied Health and science, Datta Meghe Institute of Higher Education and Research Sawangi,Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9561897908  
Fax    
Email  minalambilkar996@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Akash Lohakare  
Designation  Associate Professor Department of Cardiology AVBRH Sawangi,Wardha 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Cardiology AVBRH Sawangi wardha

Wardha
MAHARASHTRA
442001
India 
Phone  7525859055  
Fax    
Email  akashlohakare@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Akash Lohakare  
Designation  Associate Professor Department of Cardiology AVBRH Sawangi,Wardha 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Cardiology AVBRH Sawangi wardha


MAHARASHTRA
442001
India 
Phone  7525859055  
Fax    
Email  akashlohakare@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research 
 
Primary Sponsor  
Name  Dr Minal Gopichand Ambilkar 
Address  Dept. of Clinical research , Datta Meghe Institute of Higher Education and research , Sawangi Wardha 442001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Minal Ambilkar  Acharya Vinoba Bhave Rural Hospital  Sawangi Wardha
Wardha
MAHARASHTRA 
9561867908

minalambilkar996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education And Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I209||Angina pectoris, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NA 
Comparator Agent  NIL  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Patients who are 18 years of age
2.Documented episode symptoms suggesting CAD
 
 
ExclusionCriteria 
Details  1.The age of patients less than 18 years of age
2. patients with myocarditis, cardiomyopathies, and pulmonary embolism
3.Pregnancy
4.Chronic Kidney Disease
5.Chronic Liver Disease 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of Coronary Artery Disease in Wardha District and Risk Factor   After next day of enrollment, At 1st day of the study  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NA 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Noncommunicable illnesses account for three-fifths of all fatalities in India, with coronary heart disease (CHD) ranking among the leading causes. In India, there are only a few studies available that use a pragmatic method to identify verified CHD. This study seeks to identify the prevalence of verified CHD and associated risk factors in the rural community. Cardiovascular diseases (CVD) are the main cause of death among people in India, and the risk factors (tobacco, hypertension, diabetes, overweight, and obesity) are widespread. Most risk-factor surveys have targeted young and middle-aged adults. We assessed the prevalence of risk factors for CVD among the elderly.

The presence of atherosclerosis in the coronary arteries is what defines Coronary Artery Disease (CAD). Coronary artery disease is the largest cause of death and loss of Disability Adjusted Life Years (DALYs) globally. Low and middle-income nations carry a disproportionate part of this burden, accounting for almost 7 million fatalities and 129 million DALYs annually.Coronary Artery Disease (CAD)/Ischaemic Heart Disease (IHD) is diagnosed with stable angina and Acute Coronary Syndrome (ACS). Acute coronary syndrome (ACS) almost always appears as a symptom, such as unstable angina or myocardial infarction.CAD accounted for 8.9 million fatalities and 164.0 million DALYs.


The chance of dying from CAD grows dramatically as one gets older, and systolic blood pressure is the most important modifiable risk factor, explaining some of the extra CAD hazards that come with age.

 

 
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