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CTRI Number  CTRI/2024/07/071055 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 24/06/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Establishing the Link Between Spandan Smartphone ECG and Angiography in STEMI patient Diagnosis 
Scientific Title of Study   Co-relation of coronary angiography after STEMI with ECG recording via portable smartphone based ECG device(Spandan). 
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

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

Dehradun
UTTARANCHAL
248001
India 
Phone  9061593507  
Fax    
Email  aadya1983@gmail.com  
 
Source of Monetary or Material Support  
Sunfox Technologies Private Limited, 112 Dharampur Road, Near Chillis Restraurant, Nehru colony, Dehradun, Uttarakhand, India Pincode - 248001 
 
Primary Sponsor  
Name  Sunfox Technologies Private Limited 
Address  112- Dharampur Road, Near Chillis Restraurant, Nehru colony, Dehradun, Uttarakhand 
Type of Sponsor  Other [Medical Device Manufacturer] 
 
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 Chandra Mohan  Himalayan Institute of Medical Sciences  Cardiac Care Unit, Cardiac Ward, Department of Cardiology,Himalayan Institute of Medical Sciences, Swami Rama Himalayan University jollygrant
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I708||Atherosclerosis of other arteries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients should have symptoms such as chest pain palpitations and shortness of breath. These symptoms are indicative of potential cardiac issues and make them suitable candidates for the study and Patients referred for coronary angiography are included.
 
 
ExclusionCriteria 
Details  1. History of Reperfusion: Patients with a history of reperfusion therapy are excluded. This criterion may be in place to focus on patients who have not undergone reperfusion and to avoid potential confounding factors related to prior treatments.
2. Pacemaker Rhythm: Patients with a pacemaker rhythm are excluded from the study. This exclusion criterion ensures that participants do not have devices that may interfere with the accurate recording and interpretation of ECG data using smartphone-based portable ECG devices.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome measure is the correlation between ECG recordings obtained via smartphone-based portable ECG devices and the findings of coronary angiography.
 		 6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes may include clinical outcomes (e.g., mortality rates, major adverse cardiac events), patient perspectives, and the influence of patient characteristics and confounding factors on ECG accuracy.
 		 6 Months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/08/2024 
Date of Study Completion (India) 10/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 10/08/2024 
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   The study is designed as an observational study focusing on collecting and analyzing data from patients with ST-segment elevation myocardial infarction (STEMI) who receive both smartphone-based portable ECG recordings and coronary angiography as part of
their clinical care in  100 to140 patients. It includes subjects ages above 18-75 years. and the subject has symptoms like Chest pain, shortness of breath, or pulse and also patients referred for Coronary Angiography. The primary outcome measures whether Spandan ECG can detect the occluded artery. Compared with angiography, the secondary outcome measures how precisely it determines the coronary artery occlusion. 
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