Evaluation of 4D Magnetic Resonance Angiography (K-t Blast) of Supraortic Vessels in Acute Ischemic Stroke Patients

Stroke, Acute Clinical Trial

Official title:

Evaluation of 4D Magnetic Resonance Angiography (K-t Blast) of Supraortic Vessels in Acute Ischemic Stroke Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311544
• Other study ID #: 2010-A01158-31
• Secondary ID: LOC/10-11
• Status: Completed
• Phase: N/A
• First received: March 7, 2011
• Last updated: May 15, 2012
• Start date: March 2011

Study information

• Verified date: May 2012
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial Summary

The Magnetic Resonance angiography (MRA) of supraaortic vessels is essential for the etiologic of stroke. However, the techniques usually used provide only static evaluation (degree of stenosis, occlusion) but not dynamic. An ultra-fast 3D MRA originally developed for the cardiac imaging, k-t blast (Broad-use Linear Acquisition Speed-up Technique) could be used to review the supraaortic vessels. This MRA offers the following advantages: short acquisition time, wide spatial coverage (of the thoracic aorta to the distal encephalic arteries), 3D spatial resolution and high temporal resolution. These qualities are even more optimal with a high magnetic field (3T). The high temporal resolution is interesting because it provides to repeat a volume every eight seconds and thus to have a dynamic evaluation of vascular filling and to assess the vascular supply of the infarcted territory. This sequence is classified as a 4D MRA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women over 18 years

• Eligibility for intravenous thrombolytic treatment (National Institute of Neurological Disorders and Stroke criteria)

• Permanent ischemic stroke confirm with encephalic MRI (Magnetic Resonance Imaging)

• Patient able of accepting protocol information

• Patient who received information about the protocol and had not expressed its opposition to participate

Exclusion Criteria:

• Pacemaker

• Surgical ferromagnetic clips

• Cochlear implants

• Intraocular metallic foreign body

• Iron implants or objects likely to concentrate the Radio Frequency field

• Claustrophobia

• Known intolerance to contrast media (DOTAREM)

• Pregnant women (Beta Human Chorionic gonadotrophin performed for biological assessment of thrombolysis)

• Patient with severe kidney with Glomerular Filtration rate < 30 ml/min

• Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes	Brittany

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Images quality for each cervical and intracranial arteries		6 months	No
Secondary	Quantification of carotid stenosis with NASCET classification		6 months	No
Secondary	Study of dynamic vascular consequences of carotid stenosis		6 months	No