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

August 22, 2018 updated by: Lille Catholic University

Comparison Between Enhanced Susceptibility-weighted Angiography and Time of Flight 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

34

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients included in this prospective study will be recruited at Saint-Philibert Hospital -Lomme, France, when presenting symptoms of an acute stroke

Description

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 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
Acute stroke patients
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.
Diagnostic test: Magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at inclusion

Collaborators and Investigators

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

Sponsor

Lille Catholic University

Investigators

  • Principal Investigator: Sebastien Verclytte, MD, GHICL

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)

March 1, 2014

Primary Completion (ACTUAL)

July 31, 2014

Study Completion (ACTUAL)

December 31, 2014

Study Registration Dates

First Submitted

August 22, 2018

First Submitted That Met QC Criteria

August 22, 2018

First Posted (ACTUAL)

August 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 22, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOF-SWAN

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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