Imaging of Plaque With Magnetic Resonance Imaging (MRI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Brigham and Women's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00115856
First received: June 26, 2005
Last updated: June 3, 2010
Last verified: June 2010
  Purpose

This study aims to develop and refine the use of an intravascular wire to image plaque in the aorta, iliac and femoral artery using MRI. This project aims to use this increased resolution to identify the features within the plaque that is known to be associated with increased risk of plaque and vessel occlusion.

The hypothesis is Intravascular MRI can detect and measure changes in response to therapy over time in the critical features in plaques in peripheral arteries of patients with atherosclerosis.


Condition Intervention Phase
Arterial Occlusive Disease
Procedure: Intravascular MRI
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Imaging of Plaque in Atherosclerosis With Intravascular MRI

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Study Start Date: January 2001
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Detailed Description:

For those patients undergoing cardiac catheterization, an 8Fr sheath will be introduced via a femoral artery approach. This size sheath allows us to visualize the distal aorta while performing the IVUS. For these patients, if a femoral venous sheath is also positioned for clinical purposes, then this access will also be utilized to introduce the MRI coil. This imaging approach will allow us to compare the feasibility of intravascular MRI imaging from: a) the artery; b) the vein; c) a combination of both.

For those patients not scheduled to undergo a clinically indicated cardiac catheterization, only a 6Fr sheath will be introduced via a femoral artery approach. In these patients, no femoral venous sheath will be introduced and the arterial access will not be upsized to a 8Fr sheath.

Two tablespoons of blood will be drawn from each patient to assess inflammatory markers such as C-Reactive Protein (CRP) as well as to confirm a negative pregnancy test for female patients of childbearing age.

Using 20cc of non-ionic contrast, an angiogram of the distal aorta and the ilio-femoral region will be performed and recorded on disc (5mins). Thereafter, an approved guidewire and intravascular ultrasound catheter will be positioned in the same arteries via the same access route, and ultrasound images of the arterial segment will be recorded (10mins.). The guidewire and the ultrasound coil will then be removed. Finally, an intravascular MRI wire will be advanced through the same arterial access and/or the previously indicated venous access under X-ray control and positioned in the desired atherosclerotic segment in the region of the distal aorta or at the ilio-femoral area. The MRI wire(s) will be secured in place by Tegaderm and the femoral sheath(s) will be sutured in stable position. The patient will then be transported to the MRI scanner, positioned in the scanner and images recorded over a period not exceeding 60 minutes. During the transport and throughout the MRI scanning, the patient will be monitored via an MRI-compatible cardiac monitor. During the time that the intravascular MRI coil is within the femoral sheath, it will be continuously perfused with heparinized saline and the patient will receive weight- adjusted (12 U/kg) intravenous heparin for systemic anticoagulation to prevent thrombosis. To obtain the MRI images, the patients will receive gadolinium contrast as per routine radiology protocols (0.1-0.2 mmol/kg). After recording the MRI images, the MRI coil(s) and the femoral sheath(s) will be removed from the artery and/or the vein as per usual care.

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Male and female adults (aged 25-80) seen at the Brigham and Women's Hospital (BWH) clinic who have known arterial disease who consent to cannulation of the femoral artery for this research.
  • Patients in the prespecified age group who are scheduled to undergo a clinically indicated heart or peripheral catheterization at the BWH catheterization (cath) lab who will have a tube (sheath) already positioned in their femoral artery
  • Patient must be in stable condition with regard to symptoms, vital signs and the monitored electrocardiogram

Exclusion Criteria:

  • Unstable symptoms, vital signs or electrocardiogram after the heart cath
  • Any complications during the heart cath (eg., bleeding, angina, arrhythmias, technical difficulties cannulating the femoral artery)
  • Creatinine >2.0mg/dl
  • Pregnancy
  • Contraindications to anticoagulation
  • Patients with a metal implant, pacemaker, cardiac defibrillator, metal fragments in the eye, bullets/metal objects in the body
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115856

Contacts
Contact: Andrew Selwyn, MD 617-732-7133 aselwyn@partners.org
Contact: Peter Ganz, MD 617-732-7133 pganz@aol.com

Locations
United States, Massachusetts
Brigham and Womens Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Andrew Selwyn, MD    617-732-7133    aselwyn@partners.org   
Sub-Investigator: Peter Ganz, MD         
Sub-Investigator: Eric Larose, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Andrew Selwyn, MD Brigham and Womens Hospital
  More Information

No publications provided

Responsible Party: Andrew Selwyn, MD, Brigham & Women's Hospital
ClinicalTrials.gov Identifier: NCT00115856     History of Changes
Other Study ID Numbers: 2001P-000114
Study First Received: June 26, 2005
Last Updated: June 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Arterial Disease

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014