Non-Contrast Enhanced Peripheral Magnetic Resonance Angiography

Peripheral Arterial Disease Clinical Trial

Official title:

Non-Contrast Enhanced Peripheral Magnetic Resonance Angiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02823444
• Other study ID #: 50494
• Status: Completed
• Start date: April 2008
• Est. completion date: June 30, 2018

Study information

• Verified date: January 2020
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years