| CTRI Number |
CTRI/2024/08/072873 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding the utility of MRI sequences in the evaluation of brain Stroke |
|
Scientific Title of Study
|
Quantification of Ischemic Lesion using Intravoxel Incoherent Motion and
prediction of Motor Outcome with Diffusion Kurtosis Imaging in Acute 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 |
Tancia Pires |
| Designation |
Ph.D. Scholar |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Medical Imaging Technology
Manipal College of Health Professions
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9545055746 |
| Fax |
|
| Email |
tancia.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka |
| Designation |
Assistant Professor (Senior scale) |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Medical Imaging Technology
Manipal College of Health Professions
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9739314908 |
| Fax |
|
| Email |
priyanka.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka |
| Designation |
Assistant Professor (Senior scale) |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Medical Imaging Technology
Manipal College of Health Professions
Manipal Academy of Higher Education
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9739314908 |
| Fax |
|
| Email |
priyanka.rao@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Kasturba Hospital
MAHE Manipal
Karnataka
Pin 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Manipal College of Health Professions
MAHE Manipal
Karnataka
Pin 576104 |
| Type of Sponsor |
Research institution |
|
|
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 Rajagopal KV |
Kasturba Hospital |
Main MRI room
Near emergency block
Department of Radiodiagnosis and Imaging
Udupi
KARNATAKA |
9448158901
rajagopal.kv@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I63||Cerebral infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Phase 1
Patients with first ever stroke and early stroke symptoms like Upper or lower limb weakness
slurring of speech or blurring of vision
Time between the onset of symptoms and MRI scan less than 24 hours
Phase 2
1 Unilateral first-ever stroke occurred due to middle cerebral artery occlusion |
|
| ExclusionCriteria |
| Details |
Phase 1
Presence of any hemorrhage traumatic or space-occupying lesion in the brain
Ischemic lesions smaller than 0.5 cm
Those having a non-penumbra core on imaging
Phase 2
Multiple Focal infarcts
Patients with a history of motor disability due to other underlying causes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
phase 1
IVIM parameters and NIHSS score
Phase 2
DKI parameters and Fugl-Meyer assessment score at baseline, 1 and 3 months after stroke |
baseline, 1 and 3 months after stroke |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NA |
NIL |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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)
|
02/09/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Objectives Phase 1 To assess the utility of the hybrid IVIM sequence to differentiate the ischemic core from the penumbra To determine the association between the IVIM parameters and stroke severity Phase 2 To analyze whether DKI parameters predict motor outcomes 1 and 3 months after acute ischemic stroke To compare the DKI parameters in the lesioned and the contralateral hemispheres along the pathway in the brain Procedure Phase 1 The thoroughly signed informed consent from the patient, if conscious, if not from the patient’s legal guardian, and later, once the patient is stable, the patient’s signature will also be obtained. Those who meet the inclusion criteria will undergo an MRI brain-stroke protocol. The IVIM raw data will be post-processed using in-built software to acquire parametric maps for relative Cerebral blood flow (rCBF), Diffusion Coefficient (D), pseudo-diffusion coefficient (D*), and perfusion fraction (f). An ellipse ROI will be placed in the core. A symmetrical ROI will be placed in the contralateral normal hemisphere of the brain, and the third ROI will be placed in the penumbra. The numerical values obtained as Mean ± SD will then be tabulated. The baseline NIHSS score will be noted. Phase 2 Those fitting the inclusion criteria will undergo the MRI brain stroke protocol after signing an informed consent. The obtained DKI raw data will be post-processed using the Diffusion analysis software. Ellipse ROI will be placed in the following regions of the affected as well as the contralateral hemisphere: ischemic lesion, precentral gyrus, supplementary motor area, post-central gyrus, Posterior Limb of Internal Capsule, corona radiata, corpus callosum, and perilesional white matter. The parametric values from each Mean Diffusivity (MD), Fractional Anisotropy (FA), Mean Kurtosis (MK), Radial Kurtosis (RK), Axial Kurtosis (AK), and Kurtosis Anisotropy (KA) will be obtained for all the ROIs. A physiotherapist will evaluate the baseline Fugl Meyer assessment (FMA) score for the upper and lower limbs. When the patient arrives for the standard 1-month follow-up, the FMA score will be noted. At 3rd month follow-up FMA score will again be noted. Significance of the study This study will aid in the early detection of salvageable tissue in cases of acute ischemic stroke, which then, if treated immediately, will prevent the further deterioration of tissue that would otherwise lead to catastrophic complications. It will also aid in determining the amount of motor damage already caused in the acute setting, thereby enabling appropriate treatment and rehabilitation measures to be taken accordingly, leading to a better prognosis. |