NCT02823444

Non-Contrast Enhanced Peripheral Magnetic Resonance Angiography

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Peripheral Arterial Disease
• Intermittent Claudication
• Peripheral Vascular Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-04-01
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2016-07-06
• Last updated: 2023-04-24

Locations

1 site across 1 country: United States