Susceptibility Weighted Imaging for Detection of Thrombus in Acute Ischemic Stroke.

February 17, 2023 updated by: Sushanta Paudel, Upendra Devokta Memorial National Institute of Neurology and Allied Scicences

Susceptibility Weighted Imaging for Detection of Thrombus in Acute Ischemic Stroke: a Cross-sectional Study.

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 (NIHSS).Among 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 hemor¬rhagic transformation cases were not included in the study due to suboptimal SVS quantification.

MRI Protocol: MRI will done in 1.5T unit (Siemens, Magnetom, Essenza). Different parameters for SWI as follows at 1.5T: echo time (TE) = 40 ms, repetition time (TR) = 29 ms, slice thickness = 0.7 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 = 7.15 ms, FOV = 168 × 200 mm, slice thickness = 0.7 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 <0.05. 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 Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nepal
    • Bagmati
      • Bharatpur, Bagmati, Nepal, 44600
        • Sushanta Paudel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the patients with stroke admitted to the hospital from July 2021 to July 2022 were included in this study.

Description

Inclusion Criteria:

  • Anterior circulation stroke established by diffusion-weighted imaging (DWI),
  • MRI performed within 72 hours of stroke onset,
  • Patient with occlusion of the vessel on MRA (Magnetic Resonance Angiography).
  • MRI performed before or during intravenous thrombolysis (IVT) or mechanical thrombectomy (MT).

Exclusion Criteria:

• Infarcts with hemorrhagic transformation cases were not included in the study due to suboptimal SVS quantification.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with acute ischemic stroke
All the patients with stroke admitted to the hospital from July 2021 to July 2022 were included in this study. Patients with the following criteria were 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 hemor¬rhagic transformation cases were not included in the study due to suboptimal SVS quantification
Diagnostic test: Magnetic resonance imaging
MRI was done in 1.5T unit (Siemens, Magnetom, Essenza). Different parameters for SWI as follows at 1.5T: echo time (TE) = 40 ms, repetition time (TR) = 29 ms, slice thickness = 0.7 mm, flip angle = 25°, field of view (FOV) = 184 × 200, intersection gap = 0 mm, and matrix size = 322 × 225. MRA parameters were as follows: TR = 29 ms, TE = 7.15 ms, FOV = 168 × 200 mm, slice thickness = 0.7 mm, flip angle = 25°, with acquisition time of 3 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients Demographics and risk factor
Time Frame: one year
Among total number of patients included in this study patients will be assessed as name , age ,sex, risk factor. Risk factors for stroke of the patients included in this study will tabulated such as smoking, heart disease, alcohol etc .
one year
Site of occlusion
Time Frame: one year
The site of occlusion on Magnetic resonance angiography will be tabulated such as Middle cerebral artery, Anterior cerebral artery etc
one year
Presence of SVS on SWI
Time Frame: one year
Presence of Susceptible vascular sign (SVS) on susceptibility weighted imaging (SWI) in patients with MR angiography positive vessel occlusion will be calculate in percentage
one year
Sub group analysis for positive susceptible vascular sign
Time Frame: one year
Subgroup analysis of presence of SVS on SWI will be done as per site of occlusion , risk factor, age ,sex and mean thrombus length
one year
Association of Positive SVS on SWI with Different factors
Time Frame: one year
Chi-square test will be done to find out the correlation between the SVS with territorial occlusion and presence of SVS on SWI with the risk factor.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Upendra Devokta Memorial National Institute of Neurology and Allied Scicences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

December 20, 2022

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

February 17, 2023

First Posted (Estimate)

February 21, 2023

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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