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

NCT ID: NCT00834548

Last Updated: 2009-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Atherosclerosis Intermittent Claudication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

WB-MRA standard protocol

Whole body magnetic resonance angiography (WB-MRA)

Intervention Type PROCEDURE

WB-MRA will be performed once in each patient.

2

WB-MRA hybrid protocol

Whole body magnetic resonance angiography (WB-MRA)

Intervention Type PROCEDURE

WB-MRA will be performed once in each patient.

Interventions

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Whole body magnetic resonance angiography (WB-MRA)

WB-MRA will be performed once in each patient.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role lead

Responsible Party

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Copenhagen University Hospital Herlev

Principal Investigators

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Yousef W Nielsen, MD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital at Herlev

Locations

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Copenhagen University Hospital Herlev

Herlev Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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Herlev WB-MRA 5

Identifier Type: -

Identifier Source: org_study_id

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