| CTRI Number |
CTRI/2024/08/073159 [Registered on: 30/08/2024] Trial Registered Prospectively |
| Last Modified On: |
26/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Risk factors for Heart Disease Among Women in Coastal Karnataka |
|
Scientific Title of Study
|
Prevalence of cardiovascular risk factors and their determinants among 40–55
year old women of coastal Karnataka - A community-based survey |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramit Mahajan |
| Designation |
doctor(post graduate resident) |
| Affiliation |
Kasturba medical college manipal |
| Address |
Department of community medicine, Kasturba Medical college, manipal academy of higher education, manipal,udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9991343115 |
| Fax |
|
| Email |
doc.ramit.mahajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjitha S Shetty |
| Designation |
Additional Professor |
| Affiliation |
Kasturba medical college manipal |
| Address |
Department of community medicine, Kasturba Medical college, manipal academy of higher education, manipal udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9110401395 |
| Fax |
|
| Email |
ranjitha.shetty@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjitha S Shetty |
| Designation |
Additional Professor |
| Affiliation |
Kasturba medical college manipal |
| Address |
Department of community medicine, Kasturba Medical college, manipal academy of higher education, manipal udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9110401395 |
| Fax |
|
| Email |
ranjitha.shetty@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, MAHE Manipal, Udupi.576104 Karnataka, India |
|
|
Primary Sponsor
|
| Name |
KMC, Manipal |
| Address |
Kasturba Medical College, MAHE Manipal, Udupi.576104 Karnataka, India |
| 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 Ramit Mahajan |
Kasturba medical college manipal |
Room no 1, 3rd floor, Department of community medicine,Biochemistry Building Kasturba Medical colleg, manipal academy of higher education, Madhava Nagar, Manipal Udupi 576104
Udupi
KARNATAKA |
9991343115
doc.ramit.mahajan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and kasturba hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening for Cardiovascular disease risk factors among women. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Not applicable |
| Comparator Agent |
Nil |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.Women belonging to the age group of 40- to 55-years and
2. Residing in the field practice area of Department of Community Medicine KMC Manipal. |
|
| ExclusionCriteria |
| Details |
1.Severely ill or bed ridden women who are unable to answer the questions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Prevalence of CVD risk factors among women of perimenopausal age.
2. Association between various epidemiological factors and CVD risk factors. |
15th September 2024 to 31st January 2026 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="568"
Sample Size from India="568"
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)
|
15/09/2024 |
| 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="4"
Days="15" |
|
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
|
Objectives:
1. To conduct a scoping review of the published studies to document the risk factors and disease
burden in Indian women.
2. To estimate the prevalence of CVD risk factors, in the women of 40 - 55 year age group in coastal
Karnataka.
3. To identify the determinants of CVD risk factors among the study population.
4. Estimate the CVD risk among the surveyed women using WHO/ISH risk score. Tools used - 1. WHO STEPwise approach for NCD risk
factors surveillance (STEPS) 2. Pittsburgh Sleep quality index 3. Perceived stress scale for stress 4. tape measures, Sphygmomanometer 5. Glucometer 6.weighing scales 7.Google forms will be created for the attached questionnaire to enter and compile the details. Data collection Methodology- A house to house survey will be conducted. The study will be explained to the participants
using the participant information sheet and written informed consent will be obtained from all the
participants in the local language (Kannada) before recruiting them into the study. This will be followed by anthropometric measurements
(height weight waist-hip ratio) pulse rate and blood pressure measurements. Laboratory report
documentation will be the next step. The participants will be asked for any lab investigation done in the
past 1 year, if the reports are available for Fasting blood sugar (FBS) total cholesterol, urinary sodium
and urinary creatine will be documented. If reports are unavailable, participants will be requested to get
these tests done from nearby PHC. |