NCT00554073

Brief Summary

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

August 19, 2009

Status Verified

August 1, 2009

First QC Date

November 5, 2007

Last Update Submit

August 18, 2009

Conditions

AtherosclerosisIntermittent ClaudicationMRI

Keywords

Magnetic resonancewhole bodyangiographyvasovistgadofosvesetblood pool agent3T1.5TField strength

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with intermittent claudication (pheripheral arterial disease)

You may qualify if:

  • Symptomatic lower extremity ischemia (claudication, ischemic wounds) Referred to digital subtraction angiography (DSA)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiology, Herlev University Hospital

Herlev Copenhagen, Herlev, DK2730, Denmark

Location

MeSH Terms

Conditions

AtherosclerosisIntermittent Claudication

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Arterial DiseasePeripheral Vascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Henrik S Thomsen, Prof. MD.

    University Hospital at Herlev Copenhagen Denmark

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 5, 2007

First Posted

November 6, 2007

Study Start

May 1, 2008

Study Completion

August 1, 2009

Last Updated

August 19, 2009

Record last verified: 2009-08

Locations

DK(1)