An observational study in Peripheral Arterial Disease, Intermittent Claudication and Peripheral Vascular Disease, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-24.
Sponsored by University of Utah · Observational
To systematically develop, test, and refine peripheral vascular electrocardiography-gated fast spin echo magnetic resonance imaging for the accurate diagnosis of peripheral arterial disease without gadolinium contrast.
To test prospectively the accuracy of fast spin echo in peripheral arterial disease patients, compared with bolus-chase and time-resolved gadolinium enhanced magnetic resonance angiography. Additionally, as a substudy of this project, we will compare our fast spin echo approach with alternative non-contrast-enhanced magnetic resonance imaging methods such as time-of-flight and steady-state gradient echo imaging.
The overarching goals of our research are to develop and validate a peripheral magnetic resonance imaging technique that accurately depicts anatomy and disease without exposing patients to exogenous contrast material and its associated risks.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 200 is close to the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
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Population will be patients recruited from the University of Utah and Salt Lake City Veteran Affairs Medical Center. The intended gender distribution of the subjects will be approximately equal. There will be no gender based enrollment restrictions. The age range of the subjects is 18-95. No children will be recruited, as peripheral arterial disease is a disease of adulthood, with increased prevalence in the elderly population. There are no enrollment restrictions based upon race or ethnic origin. Patients with stents may be included.
Exclusion Criteria:
Gender distribution will be approximately equal. The age range is 18-95, with increased prevalence in the elderly population.
Other: Magnetic Resonance Angiography
In the initial sequence optimization stage, healthy volunteers will also be recruited.
Other: Magnetic Resonance Angiography
Subjects who agree to participate in the study and provide written informed consent will undergo three station (abdomen/pelvis, thighs, and calves/feet) contrast and non-contrast enhanced magnetic resonance angiography of the lower extremities. Study visits may be split into two imaging sessions to decrease the time the participant is in the scanner if necessary. For image quality review, several participant may undergo only abdomen/pelvis imaging. Performance of the non-contrast magnetic resonance angiography requires placement of magnetic resonance imaging compatible electrocardiography leads on the patient's chest, so that the heart rate can be monitored and images can be obtained timed to each individual patient's heart beat. Electrocardiography monitoring/gating is performed routinely, and is not investigational.
Image Analysis
Image analysis of the non-contrast and contrast enhanced magnetic resonance angiography images from each patient will be performed by experienced readers. Each regional endpoints will be provided by each of the independent readers using non-contrast and contrast enhanced magnetic resonance angiography techniques. Each regional endpoint also will be provided by a consensus of the readers using all of the data from the magnetic resonance angiography techniques. Mixed model regression will be used to compare imaging methods in terms of overall image quality and reader confidence, with each endpoint analyzed separately and represented for each extremity as an average over readers.
Time frame: 2 years
Plan to share: No
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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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