Imaging of Plaque With Magnetic Resonance Imaging (MRI)
Recruitment status was Recruiting
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| First Received Date ICMJE | June 26, 2005 | ||||||||
| Last Updated Date | June 3, 2010 | ||||||||
| Start Date ICMJE | January 2001 | ||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00115856 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Imaging of Plaque With Magnetic Resonance Imaging (MRI) | ||||||||
| Official Title ICMJE | Imaging of Plaque in Atherosclerosis With Intravascular MRI | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Arterial Occlusive Disease | ||||||||
| Intervention ICMJE | Procedure: Intravascular MRI | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | Not Provided | ||||||||
| Estimated Completion Date | June 2011 | ||||||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 25 Years to 80 Years | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00115856 | ||||||||
| Other Study ID Numbers ICMJE | 2001P-000114 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Andrew Selwyn, MD, Brigham & Women's Hospital | ||||||||
| Study Sponsor ICMJE | Brigham and Women's Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Brigham and Women's Hospital | ||||||||
| Verification Date | June 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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