Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05738070
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2023-01-19
Brief Title:
Susceptibility Weighted Imaging for Detection of Thrombus in Acute Ischemic Stroke
Sponsor:
Upendra Devokta Memorial National Institute of Neurology and Allied Scicences
Organization:
Upendra Devokta Memorial National Institute of Neurology and Allied Scicences
Study Overview
Official Title:
Susceptibility Weighted Imaging for Detection of Thrombus in Acute Ischemic Stroke a Cross-sectional Study
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is a retrospective cross-sectional study where consecutive stroke patients with vessel occlusion on magnetic resonance angiography MRA will be included for the study for one year The relation of Susceptibility vascular sign SVS on Susceptibility Weighted Imaging SWI with risk factors and territory involved and length of thrombus will correlated with the National Institutes of Health stroke scale NIHSSAmong total number of patients included in this study the demographics of the patients will be calculated Risk factors for stroke of the patients included in this study will tabulated The site of occlusion will be tabulated The mean NIHSS scale will be calculated Presence of SVS in patients with MR angiography positive vessel occlusion will be calculate in percentage Subgroup analysis of presence of SVS on SWI will be done The mean length of the thrombus will be calculated in these patients with positive SVS
Correlation between SVS on SWI with the risk factor of the patient by using the chi-square test will be calculated A Chi-square test will be done to find out the correlation between the SVS with territorial occlusion The correlation between the NIHSS score and length of thrombus will be calculated using the Pearson test
SWI can be useful in identifying the location of the thrombus and NIHSS can determine the thrombus length in acute stroke A higher incidence of SVS can be associated with risk factors and it also depends upon the site of occlusion of the vessel
Correlation between SVS on SWI with the risk factor of the patient by using the chi-square test will be calculated A Chi-square test will be done to find out the correlation between the SVS with territorial occlusion The correlation between the NIHSS score and length of thrombus will be calculated using the Pearson test
SWI can be useful in identifying the location of the thrombus and NIHSS can determine the thrombus length in acute stroke A higher incidence of SVS can be associated with risk factors and it also depends upon the site of occlusion of the vessel
Detailed Description:
Methodology
This study will conducted at a tertiary level hospital with prior ethical approval from the institutional review committee and consent from the patient will taken with the consent form It was a retrospective cross-sectional study design
Patient selection All the patients with stroke admitted to the hospital from July 2021 to July 2022 will included in this study Patients with the following criteria will be included in the study 1 anterior circulation stroke established by diffusion-weighted imaging DWI 2 MRI performed within 72 hours of stroke onset 3 Patient with occlusion of the vessel on MRA Magnetic Resonance Angiography 4 MRI performed before or during intravenous thrombolysis IVT or mechanical thrombectomy MT Infarcts with hemorrhagic transformation cases were not included in the study due to suboptimal SVS quantification
MRI Protocol MRI will done in 15T unit Siemens Magnetom Essenza Different parameters for SWI as follows at 15T echo time TE 40 ms repetition time TR 29 ms slice thickness 07 mm flip angle 25 field of view FOV 184 200 intersection gap 0 mm and matrix size 322 225 MRA parameters are as follows TR 29 ms TE 715 ms FOV 168 200 mm slice thickness 07 mm flip angle 25 with acquisition time of 3 minutes
Imaging analysis Two blinded radiologists who are blinded to the clinical characteristics and other MRI images reviewed the SWI images independently The criteria for detection of SVS as a hypointense signal within the artery on SWI is more than the size of the diameter of the homologous contralateral artery The length of SVS within M1 MCA will be determined by the largest length of SVS at the particular slice Signal loss within the vessel will termed vessel occlusion on MRA A vascular neurointerventionists who will be blinded to the clinical characteristics and other MRI images will review the MRA for detection of vessel occlusion
Statistics The data will be analyzed in Statistical Package for Social Sciences SPSS software ver 21 IBM Armonk New York The statistical value are significant when as p-value was 005 A Chi-square test will be done to find out the correlation between SVS on SWI with patient risk factors and SVS on SWI with territory involved The correlation will be calculated between the size of the thrombus and the NIHSS score
This study will conducted at a tertiary level hospital with prior ethical approval from the institutional review committee and consent from the patient will taken with the consent form It was a retrospective cross-sectional study design
Patient selection All the patients with stroke admitted to the hospital from July 2021 to July 2022 will included in this study Patients with the following criteria will be included in the study 1 anterior circulation stroke established by diffusion-weighted imaging DWI 2 MRI performed within 72 hours of stroke onset 3 Patient with occlusion of the vessel on MRA Magnetic Resonance Angiography 4 MRI performed before or during intravenous thrombolysis IVT or mechanical thrombectomy MT Infarcts with hemorrhagic transformation cases were not included in the study due to suboptimal SVS quantification
MRI Protocol MRI will done in 15T unit Siemens Magnetom Essenza Different parameters for SWI as follows at 15T echo time TE 40 ms repetition time TR 29 ms slice thickness 07 mm flip angle 25 field of view FOV 184 200 intersection gap 0 mm and matrix size 322 225 MRA parameters are as follows TR 29 ms TE 715 ms FOV 168 200 mm slice thickness 07 mm flip angle 25 with acquisition time of 3 minutes
Imaging analysis Two blinded radiologists who are blinded to the clinical characteristics and other MRI images reviewed the SWI images independently The criteria for detection of SVS as a hypointense signal within the artery on SWI is more than the size of the diameter of the homologous contralateral artery The length of SVS within M1 MCA will be determined by the largest length of SVS at the particular slice Signal loss within the vessel will termed vessel occlusion on MRA A vascular neurointerventionists who will be blinded to the clinical characteristics and other MRI images will review the MRA for detection of vessel occlusion
Statistics The data will be analyzed in Statistical Package for Social Sciences SPSS software ver 21 IBM Armonk New York The statistical value are significant when as p-value was 005 A Chi-square test will be done to find out the correlation between SVS on SWI with patient risk factors and SVS on SWI with territory involved The correlation will be calculated between the size of the thrombus and the NIHSS score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None