| CTRI Number |
CTRI/2024/07/070766 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation and comparison of Duration parameters and Amplitudes parameters of Spandan PRO ECG machine |
|
Scientific Title of Study
|
Evaluation of interval, duration, and amplitude of ECG in smartphone based ECG device as compared to GOLD Standard. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandra Mohan Belwal |
| Designation |
Associate Professor |
| Affiliation |
Himalayan institute of Medical Sciences |
| Address |
Department of Cardiology, Himalayan Institute of Medical Sciences,
Swami Rama Himalayan University (SRHU) Jollygrant, dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9061593507 |
| Fax |
|
| Email |
aadya1983@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chandra Mohan Belwal |
| Designation |
Associate Professor |
| Affiliation |
Himalayan institute of Medical Sciences |
| Address |
Department of Cardiology, Himalayan Institute of Medical Sciences,
Swami Rama Himalayan University (SRHU) Jollygrant, dehradun
UTTARANCHAL
248001
India |
| Phone |
9061593507 |
| Fax |
|
| Email |
aadya1983@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chandra Mohan Belwal |
| Designation |
Associate Professor |
| Affiliation |
Himalayan institute of Medical Sciences |
| Address |
Department of Cardiology, Himalayan Institute of Medical Sciences,
Swami Rama Himalayan University (SRHU) Jollygrant, dehradun
UTTARANCHAL
248001
India |
| Phone |
9061593507 |
| Fax |
|
| Email |
aadya1983@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sunfox Technologies Private Limited
Address -112- Dharampur Road, Near Chillis Restraurant, Nehru colony,
Dehradun, Uttarakhand
|
|
|
Primary Sponsor
|
| Name |
Sunfox Technologies Private Limited |
| Address |
112- Dharampur Road, Nehru Colony, near chilis restaurant, Dehradun |
| Type of Sponsor |
Other [Medical Device Manufacturer] |
|
|
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 Chandra Mohan |
Himalayan Institute of Medical Sciences |
ECG Room, Department of Cardiology, Himalayan Institute of Medical Sciences
Swami Rama Himalayan University Jollygrant dehradun
Dehradun
UTTARANCHAL |
9061593507
aadya1983@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Swami Rama Himalayan University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I200||Unstable angina, (2) ICD-10 Condition: I209||Angina pectoris, unspecified, (3) ICD-10 Condition: I210||ST elevation (STEMI) myocardial infarction of anterior wall, (4) ICD-10 Condition: I211||ST elevation (STEMI) myocardial infarction of inferior wall, (5) ICD-10 Condition: I212||ST elevation (STEMI) myocardial infarction of other sites, (6) ICD-10 Condition: I213||ST elevation (STEMI) myocardial infarction of unspecified site, (7) ICD-10 Condition: I214||Non-ST elevation (NSTEMI) myocardial infarction, (8) ICD-10 Condition: I214||Non-ST elevation (NSTEMI) myocardial infarction, (9) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, (10) ICD-10 Condition: I21A||Other type of myocardial infarction, (11) ICD-10 Condition: I249||Acute ischemic heart disease, unspecified, (12) ICD-10 Condition: I440||Atrioventricular block, first degree, (13) ICD-10 Condition: I491||Atrial premature depolarization, (14) ICD-10 Condition: I493||Ventricular premature depolarization, (15) ICD-10 Condition: I499||Cardiac arrhythmia, unspecified, (16) ICD-10 Condition: I498||Other specified cardiac arrhythmias, (17) ICD-10 Condition: I480||Paroxysmal atrial fibrillation, (18) ICD-10 Condition: I481||Persistent atrial fibrillation, (19) ICD-10 Condition: I483||Typical atrial flutter, (20) ICD-10 Condition: I484||Atypical atrial flutter, (21) ICD-10 Condition: I441||Atrioventricular block, second degree, (22) ICD-10 Condition: I447||Left bundle-branch block, unspecified, (23) ICD-10 Condition: I471||Supraventricular tachycardia, (24) ICD-10 Condition: I479||Paroxysmal tachycardia, unspecified, (25) ICD-10 Condition: I10||Essential (primary) hypertension, (26) ICD-10 Condition: I706||Atherosclerosis of nonbiological bypass graft(s) of the extremities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
All IPD and OPD patients referred by the cardiologist for ECG tests in the ECG laboratory will be included
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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
|
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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. |
2 Months |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
Final Enrollment numbers achieved (Total)= "1000"
Final Enrollment numbers achieved (India)="1000" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 is designed as a prospective, single-blinded, cross-sectional comparison to evaluate parameters and amplitude against a gold-standard ECG device in 1,000 patients. It includes all patients referred by a cardiologist for an ECG test in the ECG room, excluding those with underlying electrical disturbances and motion artifacts. Pregnant women and individuals with loose skin or a high density of chest hair are also excluded. The primary outcome measure focuses on evaluating the intervals, durations, and amplitude of the ECG in comparison to the gold standard. The secondary outcome measure aims to validate the accuracy of Spandan 12 Lead ECG in trace detection |