NCT05738070

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 (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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

January 19, 2023

Last Update Submit

February 17, 2023

Conditions

Keywords

Susceptibility vessel sign (SVS), MR angiography (MRA), thrombus length (TL)

Outcome Measures

Primary Outcomes (5)

  • 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 .

    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

    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

    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

    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.

    one year

Study Arms (1)

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

Interventions

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.

Patients with acute ischemic stroke

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sushanta Paudel

Bharatpur, Bagmati, 44600, Nepal

Location

Related Publications (1)

  • 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.

    PMID: 29849962BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Sushanta Paudel

Study Record Dates

First Submitted

January 19, 2023

First Posted

February 21, 2023

Study Start

July 1, 2021

Primary Completion

July 1, 2022

Study Completion

December 20, 2022

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations