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CTRI Number  CTRI/2024/12/077869 [Registered on: 09/12/2024] Trial Registered Prospectively
Last Modified On: 06/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Observing the heartbeat in patients using an application to find abnormal heartbeat patterns and comparing with ECG to know its reliability. 
Scientific Title of Study   App Based Holter Monitoring in Detecting Rhythm Abnormalities and it’s Correlation to ECG 
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 JEYARAMAN SAI PRITAM 
Designation  RESIDENT 
Affiliation  SAVEETHA MEDICAL COLLEGE AND HOSPITAL 
Address  Department of general medicine, Saveetha Medical college and hospital, Saveetha nagar, Thandalam, Chennai

Chennai
TAMIL NADU
602105
India 
Phone  7702423885  
Fax    
Email  pritamjeya24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR JEYARAMAN SAI PRITAM 
Designation  RESIDENT 
Affiliation  SAVEETHA MEDICAL COLLEGE AND HOSPITAL 
Address  Department of general medicine, Saveetha Medical college and hospital, Saveetha nagar, Thandalam, Chennai


TAMIL NADU
602105
India 
Phone  7702423885  
Fax    
Email  pritamjeya24@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR JEYARAMAN SAI PRITAM 
Designation  RESIDENT 
Affiliation  SAVEETHA MEDICAL COLLEGE AND HOSPITAL 
Address  Department of general medicine, Saveetha Medical college and hospital, Saveetha nagar, Thandalam, Chennai


TAMIL NADU
602105
India 
Phone  7702423885  
Fax    
Email  pritamjeya24@gmail.com  
 
Source of Monetary or Material Support  
Saveetha medical college and hospital, Saveetha nagar, Thandalam, Chennai 602105, Tamil nadu. India 
 
Primary Sponsor  
Name  Saveetha Medical College and Hospital 
Address  Saveetha Medical College and Hospital, Saveetha nagar, Thandalam, Chennai 602105 
Type of Sponsor  Private medical college 
 
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 Jeyaraman  Saveetha Medical College Hospital  Room no:1, Department of general medicine, OP block, Saveetha medical college and hospital, Saveetha nagar, Thandalam, Chennai
Chennai
TAMIL NADU 
7702423885

pritamjeya24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Saveetha Medical college and hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I499||Cardiac arrhythmia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patients of both sexes for whom 24 hour holter monitoring had been asked for and willing for study. 
 
ExclusionCriteria 
Details  Patients who are not willing for holter monitoring 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To elucidate the diagnostic accuracy of rhythm abnormalities detected through 24-hour holter monitoring, facilitating enhanced cardiovascular diagnostics and patient care protocols based on evidence-based findings.  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the correlation between anomalies detected through holter monitoring and those identified in 12-lead ECG findings  0 hours ECG, 24 hours holter monitoring 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
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)   17/12/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pritamjeya24@gmail.com].

  6. For how long will this data be available start date provided 20-03-2025 and end date provided 31-10-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The study will adopt a prospective cross-sectional design and will be conducted at Saveetha Medical College and Hospital over a duration of 3 months. It will involve analyzing clinical details and ECG recordings of patients scheduled for 24 hour holter monitoring. Inclusion criteria will encompass patients of both sexes aged over 18 years undergoing holter monitoring and expressing willingness to participate. Exclusion criteria will involve non cooperative patients. Data collection will entail obtaining informed consent, gathering clinical data, analyzing 12 lead ECGs for rhythm abnormalities, and examining 24 hour holter monitoring records.

 
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