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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03645902
Other study ID # TOF-SWAN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2014
Est. completion date December 31, 2014

Study information

Verified date August 2018
Source Lille Catholic University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date December 31, 2014
Est. primary completion date July 31, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Diagnostic Test:
Magnetic resonance imaging


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Lille Catholic University

Outcome

Type Measure Description Time frame Safety issue
Primary Concordance of observed agreement using eSWAN and TOF images measured by Cohen's kappa coefficient Concordance of observed agreement for the detection of arterial occlusion between eSWAN and TOF images at inclusion
Secondary Concordance inter-observer agreement for the detection of arterial occlusion using eSWAN images measured by Cohen's kappa coefficient Concordance inter-observer agreement between the two readers for the detection of arterial occlusion using eSWAN images at inclusion
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