| 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
|
|
|
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
|
|
|
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. |