Whole Body Magnetic Resonance Angiography in Ischemic Patients at 1.5 and 3T
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Purpose
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.
| Condition |
|---|
|
Atherosclerosis Intermittent Claudication MRI |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Whole Body Magnetic Resonance Angiography in Patients With Symptomatic Peripheral Ischemia: A Comparison Between 1.5 and 3T MRI-systems |
| Estimated Enrollment: | 12 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | August 2009 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with intermittent claudication (pheripheral arterial disease)
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
Contacts and Locations| Denmark | |
| Department of Radiology, Herlev University Hospital | |
| Herlev Copenhagen, Herlev, Denmark, DK2730 | |
| Study Chair: | Henrik S Thomsen, Prof. MD. | University Hospital at Herlev Copenhagen Denmark |
More Information
No publications provided
| Responsible Party: | Yousef Nielsen, Department of Radiology, Copenhagen University Hospital Herlev |
| ClinicalTrials.gov Identifier: | NCT00554073 History of Changes |
| Other Study ID Numbers: | WB-angio herlev 2 |
| Study First Received: | November 5, 2007 |
| Last Updated: | August 18, 2009 |
| Health Authority: | Denmark: National Board of Health |
Keywords provided by Copenhagen University Hospital at Herlev:
|
Magnetic resonance whole body angiography vasovist gadofosveset |
blood pool agent 3T 1.5T Field strength |
Additional relevant MeSH terms:
|
Atherosclerosis Intermittent Claudication Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013