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

NCT03645902 | Completed

• 1 other identifier: TOF-SWAN
• Study Type: observational
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke, Acute; Angiography; Magnetic Resonance Imaging; Diagnosis

Keywords

Acute stroke; Susceptibility-weighted imaging; Arterial occlusion; Time of flight

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  at inclusion

Study Arms (1)

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

Interventions

Magnetic resonance imaging DIAGNOSTIC_TEST

Acute stroke patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Lille Catholic University: lead

MeSH Terms

Conditions

Stroke; Disease; Arterial Occlusive Diseases

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sebastien Verclytte, MD

  GHICL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 24, 2018
• Study Start: March 1, 2014
• Primary Completion: July 31, 2014
• Study Completion: December 31, 2014
• Last Updated: August 24, 2018

Record last verified: 2018-08