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Trial record 2 of 58 for:    Brain Aneurysms And Imaging

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

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ClinicalTrials.gov Identifier: NCT02576743
Recruitment Status : Recruiting
First Posted : October 15, 2015
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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).

Condition or disease Intervention/treatment
Stroke 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.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Pushing Spatiotemporal Limits for 4D Flow MRI and Dynamic MRA in the Brain at Ultra-High Field
Actual Study Start Date : November 2015
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

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.




Primary Outcome Measures :
  1. Brain Flow Dynamics [ Time Frame: 2 years ]
    Altered brain flow hemodynamics in patients with aneurysms and AVMs compared to normal subjects



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576743


Contacts
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Contact: Sean Moen 612-624-6666 moen0094@umn.edu

Locations
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United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Sean Moen    612-624-6666    moen0094@umn.edu   
Principal Investigator: Bharathi Jagadeesan, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Bharathi Jagadeesan, MD University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02576743     History of Changes
Other Study ID Numbers: 15SDG25850002
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Stroke
AVM
Aneurysm