Non-Contrast Enhanced Peripheral Magnetic Resonance Angiography

NCT ID: NCT02823444

Last Updated: 2023-04-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2018-06-30

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.

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Peripheral Vascular Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Peripheral Vascular Disease

Gender distribution will be approximately equal. The age range is 18-95, with increased prevalence in the elderly population.

Magnetic Resonance Angiography

Intervention Type: OTHER

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.

Control

In the initial sequence optimization stage, healthy volunteers will also be recruited.

Magnetic Resonance Angiography

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vivian Lee, MD, PhD, MBA

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Lei Zhang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of Utah

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

50494

Identifier Type: -

Identifier Source: org_study_id