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

October 28, 2019 updated by: University of Minnesota
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 2 years
Altered brain flow hemodynamics in patients with aneurysms and AVMs compared to normal subjects
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1508M77106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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