| CTRI Number |
CTRI/2025/07/091877 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding treatment delays in the management of stroke patients and Accurate prediction of clinical outcomes |
|
Scientific Title of Study
|
Evaluating Prehospital Delays in Acute Stroke Care And Comparing The Accuracy of Stroke Scales In A South Indian Tertiary Care Teaching Hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Snehal |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions MAHE Manipal |
| Address |
Department of Emergency Medical Technology Manipal College of Health Professions MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8431839560 |
| Fax |
|
| Email |
snehal.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vimal Krishnan S |
| Designation |
Professor and Head of Department |
| Affiliation |
Kasturba Medical College and Hospital MAHE Manipal |
| Address |
Department of Emergency Medicine Kasturba Medical College and Hospital MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9995389984 |
| Fax |
|
| Email |
vimal.krishnan@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vimal Krishnan S |
| Designation |
Professor and Head of Department |
| Affiliation |
Kasturba Medical College and Hospital MAHE Manipal |
| Address |
Department of Emergency Medicine Kasturba Medical College and Hospital MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9995389984 |
| Fax |
|
| Email |
vimal.krishnan@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Emergency Medicine Kasturba Medical College Manipal Academy of Higher Education Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal Academy of Higher Education |
| Address |
Kasturba Medical College and Hospital Madhava Nagar Manipal Udupi Karnataka 576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Snehal |
Kasturba Hospital Manipal |
Department of Emergency Medicine Kasturba Medical College Manipal Academy of Higher Education
Udupi
KARNATAKA |
8431839560
snehal.mchpmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Hospital Institutional Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
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 |
Adults more than 18 Years Presenting To The Emergency Department With Suspected Acute Stroke Within 24 Hours of Symptom Onset |
|
| ExclusionCriteria |
| Details |
Patients Who Have Undergone Pharmacological or Mechanical Intervention for Acute Stroke Care Within 24 Hours of Symptoms From A Different Hospital |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration and factors Contributing to Prehospital Delays in Acute Stroke |
Symptom to ambulance call
Symptom to hospital time
Symptom to first medical contact time
Transport Time
Triage time
Symptom to our ED
ED to CT time
ED to intervention time (Pharmacological- lysis/ mechanical intervention)
ED to ICU time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of diagnostic Accuracy of Stroke Scales in Detecting Stroke in Indian settings. |
Based on pre-validated Stroke scales |
|
|
Target Sample Size
|
Total Sample Size="201"
Sample Size from India="201"
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)
|
15/08/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
The study will be conducted after obtaining IRC and IEC approval and CTRI registration. The study will be explained to the subjects if conscious and coherent and informed consent will be obtained. If the subject is unconscious, the study will be explained to the bystanders or legally authorized representative and informed consent will be obtained. The data collection will be done in the Red area and resuscitation zone or Blue area of the Emergency Department. Acquired data will be analyzed by JAMOVI statistics software version 2.4.11. |