| CTRI Number |
CTRI/2025/02/081196 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Stroke Patients: Causes and Recovery After Thrombolysis Therapy |
|
Scientific Title of Study
|
Study of clinical profile of acute stroke and outcome of patients getting thrombolysed in a tertiery care 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 |
Dr Deval Ghelani |
| Designation |
Junior Resident |
| Affiliation |
Dr D Y Patil Medical college, Navi Mumbai |
| Address |
Department of general medicine, Dr D Y Patil Medical College, Navi Mumbai, Thane
Thane
MAHARASHTRA
400706
India |
| Phone |
9409262448 |
| Fax |
|
| Email |
ghelanideval97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Purkar |
| Designation |
Professor and HOU General medicine |
| Affiliation |
Dr D Y Patil Medical college, Navi Mumbai |
| Address |
Department of general medicine, Dr D Y Patil Medical College, Navi Mumbai, Thane
Thane
MAHARASHTRA
400706
India |
| Phone |
9892971979 |
| Fax |
|
| Email |
prashpurkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deval Ghelani |
| Designation |
Junior Resident |
| Affiliation |
Dr D Y Patil Medical college, Navi Mumbai |
| Address |
Department of general medicine, Dr D Y Patil Medical College, Navi Mumbai, Thane
Thane
MAHARASHTRA
400706
India |
| Phone |
9409262448 |
| Fax |
|
| Email |
ghelanideval97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil Medical College and Hospital, Nerul, Navi Mumbai, Maharashtra, India, 400706 |
|
|
Primary Sponsor
|
| Name |
Dr Deval Ghelani |
| Address |
Department of general medicine, Dr D
Y Patil medical college, Navi Mumbai |
| Type of Sponsor |
Other [Primary Investigator ] |
|
|
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 Deval Ghelani |
Dr D Y Patil Hospital, Navi Mumbai |
OPD-1 (General medicine), OPD-16 (Neurology), Female Medicine Ward, Male Medicine Ward,Intensive care unit,Dr D Y Patil Medical college, Navi Mumbai
Thane
MAHARASHTRA |
9409262448
ghelanideval97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for biomedical and health research (IECBH) of Dr D Y Patil Medical college and hospital,Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I63||Cerebral infarction, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with acute ischemic stroke (radiological diagnosis)
2.Patients of acute stroke presenting within 4.5hr window period and undergoing thrombolysis.
3.Patients of both gender above 18 years
4.Patients giving consent for study |
|
| ExclusionCriteria |
| Details |
1.Patients with hemorrhagic stroke
2.Patients with recurrent stroke where baseline could not be established in patient undergoing thrombolysis
3.Patient of both age above 75 years
4.Patient lost to follow up |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study clinical and etiological profile of acute stroke patients |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study outcome of acute stroke patients after thrombolysis
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/03/2025 |
| 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="1"
Months="0"
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
|
AIMS AND OBJECTIVE 1) To study clinical profile of acute stroke patients 2) To study outcome of acute stroke patients after thrombolysis
|