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

This study has been completed.
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by:
Copenhagen University Hospital at Herlev
ClinicalTrials.gov Identifier:
NCT00834548
First received: August 26, 2008
Last updated: February 1, 2009
Last verified: February 2009
History of Changes
  Purpose

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.


Condition Intervention
Atherosclerosis
Intermittent Claudication
 Procedure: Whole body magnetic resonance angiography (WB-MRA)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Whole-Body MRA at 3T - A Comparison Between Two Different Scan Protocols

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Diagnostic quality of WB-MRA [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Signal to noise ratio [ Designated as safety issue: No ]
  • Contrast to noise ratio [ Designated as safety issue: No ]

Estimated Enrollment: 26
Study Start Date: June 2008
Study Completion Date: August 2008
Groups/Cohorts Assigned Interventions
1
WB-MRA standard protocol
 Procedure: Whole body magnetic resonance angiography (WB-MRA)
WB-MRA will be performed once in each patient.
2
WB-MRA hybrid protocol
 Procedure: Whole body magnetic resonance angiography (WB-MRA)
WB-MRA will be performed once in each patient.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Study Population

Patients with peripheral 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00834548

Locations
Denmark
Copenhagen University Hospital Herlev
Herlev Copenhagen, Denmark, DK 2730
Sponsors and Collaborators
Copenhagen University Hospital at Herlev
Rigshospitalet, Denmark
Investigators
Principal Investigator: Yousef W Nielsen, MD Copenhagen University Hospital at Herlev
  More Information

No publications provided

Responsible Party: Yousef Nielsen MD, Copenhagen University Hospital Herlev
ClinicalTrials.gov Identifier: NCT00834548     History of Changes
Other Study ID Numbers: Herlev WB-MRA 5
Study First Received: August 26, 2008
Last Updated: February 1, 2009
Health Authority: Denmark: National Board of Health

Keywords provided by Copenhagen University Hospital at Herlev:
Magnetic resonance
whole body
angiography
hybrid protocol
MRI

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