Comparison Between TOF and SWAN Sequences in the Detection of Arterial Occlusion in Acute Ischemic Stroke Using MRI

Completed

• Conditions: Angiography; Stroke, Acute; Magnetic Resonance Imaging; Diagnosis
• Interventions: Diagnostic Test: Magnetic resonance imaging

• Registration Number: NCT03645902
• Lead Sponsor: Lille Catholic University

Brief Summary

Optimizing the MRI protocol in acute ischemic stroke remains a challenging issue. In this field, susceptibility-weighted sequences have proved their superiority over T2. Besides the strengthened susceptibility effect, enhanced susceptibility-weighted angiography (eSWAN) sequence provides also a time-of-flight (TOF) effect, allowing the exploration of the intracranial arterial circulation. The objective of this study is to compare eSWAN and 3D TOF, considered as the reference, in the detection of arterial occlusion in acute stroke.

Detailed Description

Patients who undergo MRI for suspected acute stroke with an acute ischemic lesion on diffusion-weighted imaging (DWI) will be prospectively included in this study.eSWAN and TOF images will be analyzed under double-blind conditions by a junior radiologist and a senior neuroradiologist for the detection of arterial occlusion. eSWAN images will be assessed in order to estimate the inter-observer agreement. After a consensus, eSWAN and TOF data will be compared to calculate inter-modality agreement.

Study Timeline

• Study Start: 2014-03-01
• Primary Completion: 2014-07-31
• Study Completion: 2014-12-31
• Status Verified: 2018-08
• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-08-22
• Last Update Submitted: 2018-08-22
• Study First Posted: 2018-08-24
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• clinical symptoms compatible with acute stroke;
• time range between symptoms and magnetic resonance imaging less than 4 h 30
• presence of at least one acute ischemic lesion on the diffusion-weighted images (DWI).

Exclusion Criteria

• MR contraindications;
• negative DWI;
• differential diagnosis;
• incomplete acquisition of the full magnetic resonance imaging protocol or technical issues leading to uninterpretable eSWAN and/or TOF sequences (e.g.motion artifacts).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute stroke patients	Magnetic resonance imaging	MRI examinations will be performed on a 3 T GE MR750 W scanner. Two readers, an experienced neuroradiologist (8 years of experience in neuroradiology) and a junior radiologist (3 years of experience in general radiology) will independently analyze eSWAN and TOF images in random order, looking for arterial occlusions. Analysis will be based on a 2-point-scale: arterial occlusion, based on a local signal loss, or acceptable permeability.

Primary Outcome Measures

Name	Time	Method
Concordance of observed agreement using eSWAN and TOF images measured by Cohen's kappa coefficient	at inclusion	Concordance of observed agreement for the detection of arterial occlusion between eSWAN and TOF images

Secondary Outcome Measures

Name	Time	Method
Concordance inter-observer agreement for the detection of arterial occlusion using eSWAN images measured by Cohen's kappa coefficient	at inclusion	Concordance inter-observer agreement between the two readers for the detection of arterial occlusion using eSWAN images