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Evaluating a Heart Health Monitoring Device for people with and without heart risks

Validation of a heart health monitoring device in individuals with and without cardiovascular risk factors - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/07/091698
Enrollment
150
Registered
2025-07-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I00-I99- Diseases of the circulatory system

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil

Sponsors

Connected Health, TATA Industries Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: a.Critically ill patients b. Patients with cognitive impairment. c. Patients and volunteers above 65 years age. d. Pregnant and Lactating women.

Design outcomes

Primary

MeasureTime frame
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 ECGTimepoint: At baseline

Secondary

MeasureTime frame
Consistency of the devices readings across repeated measurements within the same individual under similar conditions Intraclass correlation coefficients for assessing reliabilityTimepoint: At Baseline

Countries

India

Contacts

Public ContactDr Deepa S

St Johns Research Insitute

deepa.sn@sjri.res.in7708736328

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026