Acute Ischemic StrokeNCT05738070
Susceptibility Weighted Imaging for Detection of Thrombus in Acute Ischemic Stroke.
An observational study of Acute Ischemic Stroke, run by Upendra Devokta Memorial National Institute of Neurology and Allied Scicences at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Magnetic resonance imaging
- Type of treatment
- Injection or infusion
- How many people
- 105 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jul 2021to 20 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients with stroke admitted to the hospital from July 2021 to July 2022 were included in this study.
Who may be able to join
- 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).
Who cannot join
- Infarcts with hemorrhagic transformation cases were not included in the study due to suboptimal SVS quantification.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Magnetic resonance imaging
- Keywords
- Susceptibility vessel sign (SVS), MR angiography (MRA), thrombus length (TL)
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Demographics and risk factor
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 .
Measured: one year
Site of occlusion
The site of occlusion on Magnetic resonance angiography will be tabulated such as Middle cerebral artery, Anterior cerebral artery etc
Measured: one year
Presence of SVS on SWI
Presence of Susceptible vascular sign (SVS) on susceptibility weighted imaging (SWI) in patients with MR angiography positive vessel occlusion will be calculate in percentage
Measured: one year
Sub group analysis for positive susceptible vascular sign
Subgroup analysis of presence of SVS on SWI will be done as per site of occlusion , risk factor, age ,sex and mean thrombus length
Measured: one year
Association of Positive SVS on SWI with Different factors
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Jul 2021
- Primary completion1 Jul 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Upendra Devokta Memorial National Institute of Neurology and Allied Scicences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sushanta Paudel, Upendra Devokta Memorial National Institute of Neurology and Allied Scicences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738070
- Sponsor's protocol ID
- 113/2021
- Status last verified
- Feb 2023
- First submitted
- 19 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Halefoglu AM, Yousem DM. Susceptibility weighted imaging: Clinical applications and future directions. World J Radiol. 2018 Apr 28;10(4):30-45. doi: 10.4329/wjr.v10.i4.30.
PubMed 29849962
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Susceptibility Weighted Imaging for Detection of Thrombus in Acute Ischemic Stroke: a Cross-sectional Study.
- ClinicalTrials.gov ID
- NCT05738070
- Acronym / sponsor ID
- 113/2021
- Conditions
- Acute Ischemic Stroke
- Keywords
- Susceptibility vessel sign (SVS), MR angiography (MRA), thrombus length (TL)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Upendra Devokta Memorial National Institute of Neurology and Allied ScicencesUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute ischemic stroke | – | Diagnostic Test: Magnetic resonance imagingAll 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients with stroke admitted to the hospital from July 2021 to July 2022 were included in this study.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (1 listed)
- Infarcts with hemorrhagic transformation cases were not included in the study due to suboptimal SVS quantification.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imagingMRI 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. | Diagnostic test | Patients with acute ischemic stroke |
Primary outcome
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 .
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
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Background: PubMed 29849962Halefoglu AM, Yousem DM. Susceptibility weighted imaging: Clinical applications and future directions. World J Radiol. 2018 Apr 28;10(4):30-45. doi: 10.4329/wjr.v10.i4.30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Upendra Devokta Memorial National Institute of Neurology and Allied Scicences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Demographics and risk factor (time frame: one year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05738070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.