Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Magnetic Resonance Imaging of Intracranial Vasculopathies (VWI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03032809
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Javier Romero, Massachusetts General Hospital

Brief Summary:
The aims of this study are to optimize MR imaging and MR angiography sequences and image reconstruction for 3T magnetic resonance imaging system scanners, which are already used in the clinical environment on patients with or with suspected intracranial vasculopathies. Improvements in these areas will have positive implications for medical diagnosis and treatment.

Condition or disease Intervention/treatment
CNS Vasculitis Other: Vessel Wall MR imaging

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: High Resolution Vessel Wall Imaging by Magnetic Resonance Imaging of Intracranial Vasculopathies
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Intracranial vasculopathy
Patients diagnosed intracranial vasculopathy will be imaged further by high resolution vessel wall MR imaging on a 3Tesla MR scanner.
Other: Vessel Wall MR imaging
Magnetic resonance images of the intracranial arteries will be acquired using the 3 Tesla MR scanners. Intracranial vessels will be imaged by high resolution vessel wall MR imaging to characterize vessel wall enhancement characteristics and wall thickness.




Primary Outcome Measures :
  1. Degree of intracranial artery vessel wall enhancement [ Time Frame: During acute phase of symptoms (approximately 0-14 days from onset of symptoms) ]
    Degree of enhancement will be categorized as circumferential, eccentric, or absent


Secondary Outcome Measures :
  1. Degree of intracranial artery vessel wall thickness [ Time Frame: During acute phase of symptoms (approximately 0-14 days from onset of symptoms) ]
    Thickness will be measured in millimeters



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Fifty (50) adult patients with intracranial vasculopathy will be enrolled.
Criteria

Inclusion Criteria:

  • adult (older than 18 years)

Exclusion Criteria:

  • electrical implants such as cardiac pacemakers or perfusion pumps
  • ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
  • ferromagnetic objects such as jewelry or metal clips in clothing
  • pregnant subjects
  • pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions
  • any greater than normal potential for cardiac arrest

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): NCT03032809


Contacts
Layout table for location contacts
Contact: Javier Romero, MD 6178402392 jmromero@mgh.harvard.edu
Contact: Emmanuel Obusez, MD 6177268320 EOBUSEZ@mgh.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Emmanuel Obusez, M.D    617-726-8320    EOBUSEZ@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital

Layout table for additonal information
Responsible Party: Javier Romero, Associate Professor of Radiology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03032809     History of Changes
Other Study ID Numbers: 2016P002505
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Vasculitis
Vasculitis, Central Nervous System
Vascular Diseases
Cardiovascular Diseases
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Autoimmune Diseases
Immune System Diseases