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

NCT ID: NCT02576743

Last Updated: 2019-10-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-09-01

Brief 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).

Detailed 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.

Conditions

Stroke

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy subjects

Subjects with no contraindications to magnetic resonance imaging will undergo 4D flow MRI scanning. 7 Tesla MRI

7 Tesla MRI

Intervention Type: DEVICE

MR imaging using a 7 Tesla MR system.

Patients

Patients with an unruptured brain aneurysm or an unruptured arteriovenous malformation (AVM) with no contraindications to magnetic resonance imaging will undergo 4D flow MRI scanning 7 Tesla MRI

7 Tesla MRI

Intervention Type: DEVICE

MR imaging using a 7 Tesla MR system.

Interventions

7 Tesla MRI

MR imaging using a 7 Tesla MR system.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bharathi Jagadeesan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1508M77106

Identifier Type: -

Identifier Source: org_study_id