Non-Contrast Enhanced Peripheral Magnetic Resonance Angiography

Completed

• Conditions: Intermittent Claudication; Peripheral Arterial Disease; Peripheral Vascular Disease
• Interventions: Other: Magnetic Resonance Angiography

• Registration Number: NCT02823444
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2016-07-01
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-06
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2020-01
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Peripheral Vascular Disease	Magnetic Resonance Angiography	Gender distribution will be approximately equal. The age range is 18-95, with increased prevalence in the elderly population.
Control	Magnetic Resonance Angiography	In the initial sequence optimization stage, healthy volunteers will also be recruited.

Primary Outcome Measures

Name	Time	Method
Image Analysis	2 years	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.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States