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

NCT02576743 | Completed DMC

• 1 other identifier: 1508M77106
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke

Keywords

Stroke; AVM; Aneurysm

Outcome Measures

Primary Outcomes (1)

• Brain Flow Dynamics

  Altered brain flow hemodynamics in patients with aneurysms and AVMs compared to normal subjects

  2 years

Study Arms (2)

Healthy subjects

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

Device: 7 Tesla MRI

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

Interventions

7 Tesla MRI DEVICE

MR imaging using a 7 Tesla MR system.

Healthy subjects; Patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects / Patients between 18 and 75

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Stroke; Aneurysm

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bharathi Jagadeesan, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 15, 2015
• Study Start: November 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: October 30, 2019

Record last verified: 2019-10

Locations

US (1)