Skip to content

Evaluation and comparison of Duration parameters and Amplitudes parameters of Spandan PRO ECG machine

Evaluation of interval, duration, and amplitude of ECG in smartphone based ECG device as compared to GOLD Standard. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/07/070766
Enrollment
1000
Registered
2024-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: I249- Acute ischemic heart disease, unspecified Health Condition 2: I219- Acute myocardial infarction, unspecified Health Condition 3: I209- Angina pectoris, unspecified Health Condition 4: I706- Atherosclerosis of nonbiological bypass graft(s) of the extremities Health Condition 5: I491- Atrial premature depolarization Health Condition 6: I440- Atrioventricular block, first degree Health Condition 7: I441- Atrioventricular block, second degree Health Condition 8: I484- Atypi

Interventions

Control Intervention1: NIL: NIL

Sponsors

Sunfox Technologies Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All IPD and OPD patients referred by the cardiologist for ECG tests in the ECG laboratory will be included

Exclusion criteria

Exclusion criteria: Subjects aged below 20 years were excluded from the study. ECG reports with underlying electrical disturbances and motion artifacts were also excluded. Pregnant females. Individuals with loosened skin and high density of chest hairs. The device is not to be used with a defibrillator.

Design outcomes

Primary

MeasureTime frame
determine the equivalency of the smartphone ECG device in comparison to the Goldstandard ECG machine for measuring the morphological parameters like PR intervals and QRS duration under the Clinical level of Agreement and less margin of error Timepoint: 2 weeks

Secondary

MeasureTime frame
To access the feasibility and usability of the smartphone based ECG device in accessing the ECG from the patients & also to evaluate its accuracy when used in ECG room.Timepoint: 2 Months

Countries

India

Contacts

Public ContactChandra Mohan Belwal

Himalayan institute of Medical Sciences

aadya1983@gmail.com9061593507

Outcome results

None listed

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