| CTRI Number |
CTRI/2025/07/091698 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating a Heart Health Monitoring Device for people with and without heart risks |
|
Scientific Title of Study
|
Validation of a heart health monitoring device in individuals with and without cardiovascular risk factors
|
| 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 Denis Xavier |
| Designation |
Consultant |
| Affiliation |
St. Johns Health Innovation Foundation |
| Address |
St. Johns Health Innovation Foundation, 141/2, 100 Ft. Road, Koramangala,Bangalore.
Bangalore
KARNATAKA
560034
India |
| Phone |
9886126801 |
| Fax |
|
| Email |
denis@sjri.res.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa S |
| Designation |
Senior Resident |
| Affiliation |
St Johns Research Insitute |
| Address |
Division of Clinical Research and Training, 2nd Floor, St Johns Research Insitute.
Bangalore
KARNATAKA
560034
India |
| Phone |
7708736328 |
| Fax |
|
| Email |
deepa.sn@sjri.res.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa S |
| Designation |
Senior Resident |
| Affiliation |
St. Johns Medical College and Research Institute |
| Address |
Division of Clinical Research and Training, St Johns Research Insitute,Kormangala, Bangalore
Bangalore
KARNATAKA
560034
India |
| Phone |
7708736328 |
| Fax |
|
| Email |
deepa.sn@sjri.res.in |
|
|
Source of Monetary or Material Support
|
| Connected Health, Division of TATA Industries Limited , 24 Homi Mody Street Mumbai Maharashatra, India 400001 |
|
|
Primary Sponsor
|
| Name |
Connected Health, TATA Industries Limited |
| Address |
1st Floor, Bombay House, 24 Homi Mody Street, Fort, Mumbai, 400001 |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kiron Varghese |
St. Johns Medical college Hospital |
Department of cardiology
Kormangala Bangalore 560034
Bangalore
KARNATAKA |
9845167912
kiron.v@stjohns.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, St John’s Medical College and Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With no CVD risk factors or history. |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Consenting adults of any gender in 3 categories with 50:50 ratio of males and females who fulfils atleast one of the following criteria
a. Healthy individuals with no risk for CVD
b. Patients with risk for CVD (DM, HT, dyslip) without a CVD event (stroke, MI, HF, PAD)
c. Patients who had a vascular event (MI or stroke) in the last one year |
|
| ExclusionCriteria |
| Details |
a.Critically ill patients
b. Patients with cognitive impairment.
c. Patients and volunteers above 65 years age.
d. Pregnant and Lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correlation between heart rate HR ECG parameters blood pressure variation and oxygen saturation SpOtwo values obtained using the heart health monitoring device and gold standard methods such as 12-lead ECG |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Consistency of the devices readings across repeated measurements within the same individual under similar conditions Intraclass correlation coefficients for assessing reliability |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
18/08/2025 |
| 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
|
This study aims to assess the performance of the heart health monitoring device in individuals with and without cardiovascular risk factors by comparing the results with Gold standards |