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Completed

NCT Number: NCT03645902

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

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.

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Key information

Conditions

Stroke, Acute Angiography Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Diagnosis Disease Magnetic Resonance Imaging Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Magnetic Resonance Imaging

Diagnostic Test

Primary outcomes

  1. Concordance of observed agreement using eSWAN and TOF images measured by Cohen's kappa coefficient

    Time frame: at inclusion

    Concordance of observed agreement for the detection of arterial occlusion between eSWAN and TOF images

Secondary outcomes

  1. Concordance inter-observer agreement for the detection of arterial occlusion using eSWAN images measured by Cohen's kappa coefficient

    Time frame: at inclusion

    Concordance inter-observer agreement between the two readers for the detection of arterial occlusion using eSWAN images

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study title

Comparison Between Enhanced Susceptibility-weighted Angiography and Time of Flight Sequences in the Detection of Arterial Occlusion in Acute Ischemic Stroke Using MRI

Acronym: TOF-SWAN

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 24, 2018
Registry last updated
Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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