Pushing Spatiotemporal Limits for 4D Flow MRI and Dynamic MRA in the Brain at Ultra-High Field

Stroke Clinical Trial

Official title:

Pushing Spatiotemporal Limits for 4D Flow MRI and Dynamic MRA in the Brain at Ultra-High Field

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576743
• Other study ID #: 1508M77106
• Status: Completed
• Start date: November 2015
• Est. completion date: September 1, 2019

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims at investigating the blood hemodynamics with high spatiotemporal resolution in patients with brain aneurysms and AVMs as well as in healthy controls. Parameters such as peak blood velocity, wall shear stress and other derived parameters will be obtained from 4D flow MRI data acquired at ultra-high field strength (7 Tesla).

Description:

The hemodynamic factors responsible for hemorrhagic stroke, resulting in wide variations in the clinical management of underlying vascular lesions, especially when they are found in asymptomatic individuals or individuals with symptoms not related to the disease. Therefore, there is an urgent need for the development of reliable biomarkers based on hemodynamic parameters, which can then enable improvements in risk assessment in patients presenting with these lesions. This need can be met by non-invasive Magnetic Resonance Imaging (MRI) techniques that provide information on high resolution vascular anatomy, visualization of cerebral hemodynamics and quantitative information about blood velocity. However, such techniques as presently employed at 1.5 or 3 Tesla are limited by spatial resolution and prolonged data acquisition times.

The primary goal of this proposal is to overcome these current limitations by exploiting Ultra-High Fields (UHF, i.e. ≥ 7 Tesla (7T)) to attain significantly higher spatial resolution, faster acquisitions and increased lesion conspicuity utilizing

• Qualitative exploration of intracranial blood hemodynamics,

• Quantitative imaging of the spatiotemporally resolved blood velocity vector,

• Derivation of hemodynamic parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects / Patients between 18 and 75

Exclusion Criteria:

• Any kind of ferromagnetic implants.

• MR-unsafe non-ferromagnetic implants.

• Cardiac pacemakers.

• A history of shrapnel or shot gun injury.

• A body mass index > 40.

• Severe claustrophobia.

• Tattoos in the head/neck area or permanent makeup.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 7 Tesla MRI
MR imaging using a 7 Tesla MR system.

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain Flow Dynamics	Altered brain flow hemodynamics in patients with aneurysms and AVMs compared to normal subjects	2 years