| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I499||Cardiac arrhythmia, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pritamjeya24@gmail.com].
- 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.
- 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. |