NCT01311544

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2011

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

First QC Date

March 7, 2011

Last Update Submit

May 15, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Images quality for each cervical and intracranial arteries

    6 months

Secondary Outcomes (2)

  • Quantification of carotid stenosis with NASCET classification

    6 months

  • Study of dynamic vascular consequences of carotid stenosis

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute ischemic stroke

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, Brittany Region, 35033, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • jean-yves gauvrit

    Rennes University Hospital

    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

March 7, 2011

First Posted

March 9, 2011

Study Start

March 1, 2011

Last Updated

May 16, 2012

Record last verified: 2012-05

Locations