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

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).

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: 7 Tesla MRI

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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University Of Minnesota Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients, age 18-75 years;

• Patients with previously un-ruptured AVMs, who have had a catheter-guided DSA for evaluation of the AVM; any Spetzler-Martin grade; patients with one or more un-ruptured AVMs regardless of symptoms
• Patients with non-symptomatic patients; one or more un-ruptured conservatively managed aneurysms, all aneurysm sizes and shapes (fusiform, saccular, sessile).

Subjects:

- healthy subjects between 18 and 75 years.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy subjects; Subjects with no contraindications to magnetic resonance imaging will undergo 4D flow MRI scanning. 7 Tesla MRI	Device: 7 Tesla MRI; 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	Device: 7 Tesla MRI; MR imaging using a 7 Tesla MR system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain Flow Dynamics	Altered brain flow hemodynamics in patients with aneurysms and AVMs compared to normal subjects	2 years

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Bharathi Jagadeesan, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimate): October 15, 2015

Study Record Updates

• Last Update Posted (Actual): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Stroke; Aneurysm; AVM
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 1508M77106