Clinical trial NCT00554073: Whole Body Magnetic Resonance Angiography in Ischemic Patients at 1.5 and 3T
Official title: Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia: A Comparison Between 1.5 and 3T MRI-systems
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Atherosclerosis
Intermittent Claudication
MRI
Keywords: Magnetic resonance
whole body
angiography
vasovist
gadofosveset
blood pool agent
3T
1.5T
Field strength
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2007-11-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with intermittent claudication (pheripheral arterial disease)

Brief summary: To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using two different magnetic resonance scanners at a field strength of 1.5 and 3T. The hypothesis is that use of the 3T system gives superior signals from the investigated arteries, when compared with 1.5T.

Detailed description: Atherosclerosis of the lower leg arteries is a common disease. Patients with this condition has symptoms of ischemia, for instance intermittent claudication (pain during exercise). Diagnosis of atherosclerosis in the legs is normally done with an interventional x-ray-based angiography (DSA- digital subtraction angiography). This is uncomfortable for the patient, and associated with risks of complications (bleeding, vascular damage, embolism).A novel approach to diagnosing atherosclerosis is the use of magnetic resonance angiography. A variant of this is the whole body magnetic resonance angiography(WB-MRA), that produce a picture of the arteries in almost the whole body (excluding the coronary arteries). WB-MRA has a number of advantages compared to DSA. It does not use ionizing radiation, is not invasive, uses a contrast medium with fewer side affects and finally gives a covers a great deal of the arteries in the body.

This study will compare WB-MRA with DSA in patients with symptoms of peripheral atherosclerosis in the lower legs.

All the patients will undergo arterial first pass whole-body MRA in the 3T-system. This will be followed by a WB-MRA steady state examination which can be performed because we use the intravascular contrast medium Vasovist, that has a prolonged intravascular life. The steady state examination will be performed in both the 3T and the 1.5T MR-system. Half the patients will have the steady state examination performed first in the 3T and then the 1.5T-system. The other half will go to the 1.5T-system first and then return to the 3T-system.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev Copenhagen
country: Denmark
facility: Department of Radiology, Herlev University Hospital
state: Herlev
Study officials:
affiliation: University Hospital at Herlev Copenhagen Denmark
name: Henrik S Thomsen, Prof. MD.
role: STUDY_CHAIR
References: