Whole-Body MRA at 3T - A Comparison Between Two Different Scan Protocols

Atherosclerosis Clinical Trial

Official title:

Whole-Body MRA at 3T - A Comparison Between Two Different Scan Protocols

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00834548
• Other study ID #: Herlev WB-MRA 5
• Status: Completed
• Phase: N/A
• First received: August 26, 2008
• Last updated: February 1, 2009
• Start date: June 2008
• Est. completion date: August 2008

Study information

• Verified date: February 2009
• Source: Copenhagen University Hospital at Herlev
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Observational

Clinical Trial Summary

To compare to different approaches in whole-body magnetic resonance angiography of patients suffering peripheral arterial disease.

Our hypothesis is that use of a new protocol improves the diagnostic quality of the WB-MRA procedure.

Description:

Patients suffering peripheral arterial disease must undergo imaging procedures before endovascular or surgical procedures.

WB-MRA is an imaging procedure that can visualise the arterial system. WB-MRA can be performed in different manners. On option is to start the scan in the head region and continue down the body to the feet (standard protocol). Another option is to use a hybrid protocol that first examines the head and lower leg followed by examination of the pelvic and upper leg region.

A comparison between the standard and hybrid protocols has not been performed in a 3T high magnetic field system, therefore we will perform such a study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Symptomatic lower extremity ischemia (claudication, ischemic wounds)

• Referred to digital subtraction angiography (DSA)

Exclusion Criteria:

• Renal insufficiency (GFR < 30 ml/min)

• Contra-indications for MRI-examination (claustrophobia, metal-implants, pacemaker)

• Dementia

• Pregnancy/lactation

• Allergy to gadolinium based MRI contrast agents

• Acute disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Intermittent Claudication

Intervention

Procedure:
• Whole body magnetic resonance angiography (WB-MRA)
WB-MRA will be performed once in each patient.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital Herlev	Herlev Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Copenhagen University Hospital at Herlev	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic quality of WB-MRA			No
Secondary	Signal to noise ratio			No
Secondary	Contrast to noise ratio			No