| CTRI Number |
CTRI/2025/08/093780 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
26/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Using a heart health app to detect early risks of heart disease, diabetes, hypertension and sleep disorders in healthy individuals. |
|
Scientific Title of Study
|
Risk stratification of Cardiovascular and other non-communicable diseases such as diabetes mellitus, hypertension and obstructive sleep apnea in apparently healthy individuals using coronary artery disease consumer app |
| Trial Acronym |
PRE-VENT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G Rajendiran |
| Designation |
HOD & Professor |
| Affiliation |
PSG Institute of Medical Sciences & Research |
| Address |
Department of Cardiology
PSG Institute of Medical Sciences and Research
Peelamedu
Coimbatore
Coimbatore TAMIL NADU 641004 India |
| Phone |
8870327407 |
| Fax |
|
| Email |
rajeng68@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr G Rajendiran |
| Designation |
HOD & Professor |
| Affiliation |
PSG Institute of Medical Sciences & Research |
| Address |
Department of Cardiology
PSG Institute of Medical Sciences and Research
Peelamedu
Coimbatore
Coimbatore TAMIL NADU 641004 India |
| Phone |
8870327407 |
| Fax |
|
| Email |
rajeng68@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr K Suvetha |
| Designation |
Professor |
| Affiliation |
PSG Institute of Medical Sciences & Research |
| Address |
Department of Cardiology
PSG Institute of Medical Sciences and Research
Peelamedu
Coimbatore
Coimbatore TAMIL NADU 641004 India |
| Phone |
9597610674 |
| Fax |
|
| Email |
suvekannappan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Philips Global Business Services |
| Address |
Survey Nos.22/1p,23/1p, 23/2p,24,25/1, 26p, Embassy Manyata business park, Block beech - E1, 2nd floor, Rachenahalli village, KR Puram Hobli, Bangalore Urban, 560045 |
| Type of Sponsor |
Other [Corporate Social Responsibility ] |
|
|
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 G Rajendiran |
PSG Institute of Medical Sciences and Research |
Room No 9,
Division of Preventive Cardiology, Department of Cardiology,
Peelemadu
Coimbatore
641004 Coimbatore TAMIL NADU |
8870327407
rajeng68@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
People aged 30 to 60 years
Knows how to operate a smart phone
knows to read and understand English
Apparently Healthy Individuals of all age groups |
|
| ExclusionCriteria |
| Details |
Known ischemic heart disease patients
Cardiomyopathies
Congenital anomalies
Known case of seriously ill health conditions heart failure, kidney failure, stroke and malignancy.
Implanted cardiac devices
Psychiatric illness/ psychiatric medications
Beta blockers /any medications interfering with heart rate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is to access the validity of the app generated risk score by comparing it with the clinical MESA score for cardiovascular disease risk assessment. |
This is a cross sectional study conducted at a single point in time, with no follow up sessions or observation period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is no secondary outcome. |
NA |
|
|
Target Sample Size
|
Total Sample Size="1000" Sample Size from India="1000"
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)
|
15/09/2025 |
| 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
|
Background: Cardiovascular diseases (CVD) and other non-communicable diseases (NCDs) such as diabetes, hypertension, and obstructive sleep apnea (OSA) are rising in prevalence, particularly in the Indian population. Early risk identification is crucial but often delayed due to reliance on symptomatic hospital-based assessments. Current risk prediction tools, though widely used, lack validation for the Indian population.
Objective: This cross-sectional study aims to assess the utility of a coronary artery disease consumer mobile application incorporating the BEATS score—a digital biomarker—to stratify CVD and NCD risk in asymptomatic individuals aged 30–60 years. The study further aims to validate the BEATS score against the MESA score and examine correlations with body fat composition and six lifestyle factors.
Methods: A total of 1,000 employees from 10 selected industries/ educational institutions within 20km radius from PSG hospitals will participate. After a 5-day app-based assessment, participants undergo clinical and laboratory evaluations including CT Coronary Calcium Score, body fat composition, blood pressure, glucose levels, lipid profile, and lifestyle assessment. The BEATS score will be compared with clinical outcomes and MESA scores to assess validity.
Expected Outcomes: The study anticipates that the BEATS score will show significant correlation with subclinical atherosclerosis and lifestyle factors, offering a non-invasive, cost-effective alternative for early CVD risk detection. Findings may support large-scale implementation of digital health tools in preventive care.
Significance: This study emphasizes the national importance of digital tools for personalized risk assessment, promoting a culture of preventive healthcare and addressing gaps in early CVD detection in the Indian population. |