| CTRI Number |
CTRI/2024/07/070344 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Use of new MRI technique to quantify brain damage in stroke patients. |
|
Scientific Title of Study
|
Comparison of penumbra quantification in acute ischemic stroke between MR SWI-DWI mismatch versus MR ASL PWI-DWI mismatch in a tertiary care hospital in coastal
Karnataka – A prospective study.
|
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anukriti Jain |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Radiodiagnosis and Imaging, Kasturba hospital, Manipal
Royal Embassy, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7003886017 |
| Fax |
|
| Email |
barjatya.anukriti@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya P S |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Radiodiagnosis and Imaging, Kasturba hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9895563264 |
| Fax |
|
| Email |
priya.ps@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya P S |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Radiodiagnosis and Imaging, Kasturba hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9895563264 |
| Fax |
|
| Email |
priya.ps@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Radiodiagnosis and Imaging, Kasturba Medical College
Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 |
| 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 Anukriti Jain |
Kasturba Medical College |
Room no. 3, Main MRI, Department of Radiodiagnosis and Imaging, Kasturba Hospital, Tiger Circle Road Madhav Nagar Eshwar Nagar Manipal Karnataka 576104
Udupi
KARNATAKA |
7003886017
barjatya.anukriti@yahoo.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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G461||Anterior cerebral artery syndrome, (2) ICD-10 Condition: G460||Middle cerebral artery syndrome, (3) ICD-10 Condition: G462||Posterior cerebral artery syndrome, |
|
|
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 |
1. Stroke symptoms lasting more than 1 hour and less than 6 hours
2. NIHSS score more than 4
|
|
| ExclusionCriteria |
| Details |
1. Patients with haemorrhagic stroke
2. Intra-cranial space occupying lesion
3. General contra-indications to MRI |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SWI-DWI mismatch is a substitute for PWI-DWI mismatch in the quantification of ischemic penumbra – yes/no. |
Within 1 to 6 hours of onset of acute ischemic stroke. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Thrombolysis post quantification of ischemic penumbra using SWI-DWI mismatch plays a significant role in improving the prognosis of patients – yes/no.
|
4 weeks from onset of stroke. |
|
|
Target Sample Size
|
Total Sample Size="67"
Sample Size from India="67"
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)
|
31/07/2024 |
| 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)
|
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
|
MRI sequences as per departmental stroke protocol will be acquired for 67 patients presenting with acute ischemic stroke. The acquired data will undergo post-processing in a semi-automated software to give the following values: ischemic penumbra volume using SWI-DWI mismatch and PWI-DWI mismatch and the data will be further analyzed to evaluate the ability of SWI-DWI mismatch to identify potentially salvageable brain tissue as compared to PWI-DWI mismatch. Follow up of course of treatment of the participants post quantification of ischemic penumbra using SWI-DWI mismatch and its impact on their prognosis will be assessed. |