Non-Contrast Enhanced Peripheral Magnetic Resonance Angiography

Utah System of Higher Education (USHE)

Status

Completed

Conditions

Peripheral Vascular Disease

Intermittent Claudication

Peripheral Arterial Disease

Treatments

Other: Magnetic Resonance Angiography

Study type

Observational

Funder types

Other

Identifiers

NCT02823444

50494

Details and patient eligibility

About

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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients with known or suspected periphery arterial disease will be recruited.
In the initial sequence optimization stage, healthy volunteers will also be recruited for magnetic resonance angiography

Exclusion criteria

Patients with moderate to end stage renal disease (estimated glomerular filtration rate < 30 ml/min/1.73m2). These patients will not be recruited as they will be unlikely to undergo routine contrast enhanced magnetic resonance angiography due to the risk of developing Nephrogenic Systemic Fibrosis.
Pregnant patients. Gadolinium chelates are a FDA Category C drug, and therefore should be avoided in pregnancy.
Claustrophobic healthy volunteers or any subject who is unable to lie flat for 60 minutes.
Glomerular filtration rate < 60ml/min/1.72m2 and coexisting history of pro inflammatory conditions such as recent surgery, sepsis or major infection, arterial or venous thrombosis.
Any history of nephrogenic systemic fibrosis
Unable/ unwilling to give informed consent
Medical contra-indications to magnetic resonance imaging: e.g. pacemakers, implanted defibrillators, cochlear implants, aneurysm clips, and prior/ current metal workers. Patients will be screened with a safety questionnaire.
Clinically unstable patients
Patients with newly placed stents will be excluded until 8 weeks post placement