Clinical trial NCT02823444: Non-Contrast Enhanced Peripheral Magnetic Resonance Angiography
Official title: Non-Contrast Enhanced Peripheral Magnetic Resonance Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Intermittent Claudication
Peripheral Vascular Disease
Keywords: Magnetic Resonance Imaging
Magnetic Resonance Angiography
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Image Analysis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Vivian Lee, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Lei Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: