| CTRI Number |
CTRI/2024/04/065164 [Registered on: 03/04/2024] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
Type of Study
Modification(s)
|
Prospective study - Longitudinal Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on continuous monitoring of heart rhythm for 72 hours, in patients who have suffered a stroke, using a patch like device, to find out the occurence of abnormal heart rhythms in such patients. |
|
Scientific Title of Study
|
A Study on 72 hour Ambulatory ECG monitoring in acute ischemic stroke |
| 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 ARAVINDH SHIVA G |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Hospital Manipal |
| Address |
Department of General medicine
No 17, 2nd floor,
New OPD building,
Kasturba Hospital,
Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9597672113 |
| Fax |
|
| Email |
aravindhshiva1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ADARSHA G K |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Hospital Manipal |
| Address |
Department of General medicine
No 17, 2nd floor,
New OPD building,
Kasturba Hospital,
Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9591706468 |
| Fax |
|
| Email |
adharsha.gk@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DR ARAVINDH SHIVA G |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Hospital Manipal |
| Address |
Department of General medicine
No 17, 2nd floor,
New OPD building,
Kasturba Hospital,
Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9597672113 |
| Fax |
|
| Email |
aravindhshiva1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General medicine
No 17, 2nd floor,
New OPD building,
Kasturba Hospital,
Manipal,
Karnataka - 576104,
India |
|
|
Primary Sponsor
|
| Name |
Department of General Medicine |
| Address |
Department of General Medicine
Kasturba Medical College
Manipal, Udupi, Karnataka - 576104,
India |
| 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 ARAVINDH SHIVA G |
KASTURBA HOSPITAL MANIPAL |
2nd floor, OPD building, Department of General Medicine,
Kasturba medical college,
Manipal, Udupi, Karnataka - 576104
Udupi
KARNATAKA |
9597672113
aravindhshiva1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba hospital Institutional Ethics Committee - 2(Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G40-G47||Episodic and paroxysmal disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All Patients who have suffered an acute ischemic stroke, and documented by CT/MRI, and undergoing 72 hour ambulatory ECG monitoring.
All patients who have suffered a transient ischemic attack (TIA).
All stroke patients whose baseline ECG is not showing atrial fibrillation. |
|
| ExclusionCriteria |
| Details |
All Patients who have suffered an acute CVA due to hemorrhagic stroke.
All patients whose baseline ECG is suggestive of atrial fibrillation.
All patients whose age less than 18 years.
All Patients who are carrying a pacemaker with atrial lead. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The incidence of cardiac arrhythmias detected by ambulatory ECG monitoring in patients with acute ischemic stroke will be calculated
The number of patients in whom anticoagulation is initiated based on the ECG monitoring report will be calculated |
Case control study for 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The detection of arrhythmias in the first 24 hours versus the next 48 hours will be compared |
Case control study for 2 years |
|
|
Target Sample Size
|
Total Sample Size="166"
Sample Size from India="166"
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)
|
01/05/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Patients who have suffered an acute ischemic stroke as per the inclusion and exclusion criteria are selected, and explained about the study and enrolled after taking informed consent from patient or patient caretakers. Baseline investigations will be noted and those patients whose baseline ECG is not suggestive of atrial fibrillation and neuroimaging suggestive of acute ischemic stroke will be evaluated with 72 hours ambulatory ECG monitoring and report will be collected after cardiologist confirmation. Abnormal rhythms if present will be noted Patients who are started on anti coagulation based on the ECG monitoring report will be noted Data will be entered in the Microsoft excel sheet and will be analysed with appropriate statistical measures, and results will be arrived. |