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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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