Arterial Occlusive Disease Clinical Trial
Official title:
Imaging of Plaque in Atherosclerosis With Intravascular MRI
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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