Whole body magnetic resonance angiography (dotarem) and Whole body magnetic resonance angiography (vasovist) in Atherosclerosis and Intermittent Claudication - Clinical Trials Registry

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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. We will investigate 2 different contrast agents used for WB-MRA. The patients will be randomized to receive either the contrast medium Dotarem or the contrast medium Vasovist. In both groups we will compare the results of WB-MRA with DSA.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - Herlev, Copenhagen, Denmark, DK-2730
    - Recruiting
    - Department of Radiology, Herlev University Hospital
    - Contact:
      
      Yousef W. Nielsen, MD.
      
      Phone Number: +45 4488 4391
      
      Email: yujwni01@heh.regionh.dk
    - Principal Investigator:
      
      Yousef W. Nielsen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Vascular diagnostic quality on the WB-MRA. Degree of arterial stenosis on the WB-MRA.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen University Hospital at Herlev

Collaborators

Rigshospitalet, Denmark

Investigators

Study Chair: Henrik S Thomsen, Prof., University Hospital at Herlev Copenhagen Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Study Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

October 1, 2007

First Submitted That Met QC Criteria