Whole Body Magnetic Resonance Angiography in Ischemic Patients at 1.5 and 3T

This study has suspended participant recruitment.
(It was not possible to perform 2 MRI studies in each patient due to practical problems. The study was not suspended due to safety issues.)
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by:
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT00554073
First received: November 5, 2007
Last updated: August 18, 2009
Last verified: August 2009
  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

Resource links provided by NLM:


Further study details as provided by Copenhagen University Hospital at Herlev:

Estimated Enrollment: 12
Study Start Date: May 2008
Estimated Study Completion Date: August 2009
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with intermittent claudication (pheripheral arterial disease)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554073

Locations
Denmark
Department of Radiology, Herlev University Hospital
Herlev Copenhagen, Herlev, Denmark, DK2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Rigshospitalet, Denmark
Investigators
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 July 26, 2014