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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00556101
Other study ID # WB-angio herlev 4
Secondary ID
Status Completed
Phase N/A
First received November 8, 2007
Last updated August 18, 2009
Start date November 2007
Est. completion date July 2009

Study information

Verified date August 2009
Source Copenhagen University Hospital at Herlev
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Observational

Clinical Trial Summary

Investigation of how the patients experience whole body MRA. After the WB-MRA the patients will fill in a questionnaire, that contains questions about the WB-MRA procedure and how the patient felt during the examination.

We expect that the patients will report a high degree of satisfaction with the WB-MRA procedure, with little discomfort.


Description:

WB-MRA is performed in patients referred for conventional x-ray based angiography. The WB-MRA is performed first in all patients.

After both examinations are completed the patients will be asked to fill in a questionnaire containing questions about their experience of the 2 procedures.

We will then compare the results for the procedures.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date July 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Whole body magnetic resonance angiography


Locations

Country Name City State
Denmark Department of Radiology, Herlev University Hospital Herlev Copenhagen Herlev

Sponsors (2)

Lead Sponsor Collaborator
Copenhagen University Hospital at Herlev Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient acceptance of Whole body MRA
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