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Imaging of Plaque With Magnetic Resonance Imaging (MRI)

Primary Purpose

Arterial Occlusive Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intravascular MRI
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arterial Occlusive Disease focused on measuring Arterial Disease

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Brigham and Womens Hospital

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Subjects studied

Arm Description

Single arm exploratory feasibility safety and efficacy study of MRI to image atherosclerosis in arteries

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 26, 2005
Last Updated
July 31, 2015
Sponsor
Brigham and Women's Hospital
Collaborators
Peter Ganz MD
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1. Study Identification

Unique Protocol Identification Number
NCT00115856
Brief Title
Imaging of Plaque With Magnetic Resonance Imaging (MRI)
Official Title
Imaging of Plaque in Atherosclerosis With Intravascular MRI
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
Peter Ganz MD

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
For those patients undergoing cardiac catheterization, an 8French sheath will be introduced via a femoral artery approach. This size sheath allows us to visualize the distal aorta while performing the intra vascular ultrasound ( 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 6French 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 8French 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Occlusive Disease
Keywords
Arterial Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects studied
Arm Type
No Intervention
Arm Description
Single arm exploratory feasibility safety and efficacy study of MRI to image atherosclerosis in arteries
Intervention Type
Procedure
Intervention Name(s)
Intravascular MRI
Intervention Description
Arterial imaging of atherosclerosis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Selwyn, MD
Organizational Affiliation
Brigham and Womens Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Imaging of Plaque With Magnetic Resonance Imaging (MRI)

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