NCT00538408

Brief Summary

To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using two different magnetic resonance contrast agents.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2007

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 3, 2009

Status Verified

February 1, 2009

First QC Date

October 1, 2007

Last Update Submit

February 1, 2009

Conditions

AtherosclerosisIntermittent Claudication

Keywords

Magnetic resonancewhole bodyangiographyvasovistgadofosvesetdotaremblood pool agent

Outcome Measures

Primary Outcomes (1)

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

Interventions

Whole body magnetic resonance angiography (dotarem)PROCEDURE
Whole body magnetic resonance angiography (vasovist)DEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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, DK-2730, Denmark

RECRUITING

MeSH Terms

Conditions

AtherosclerosisIntermittent Claudication

Interventions

gadoterate meglumine

Condition Hierarchy (Ancestors)

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

Study Officials

  • Henrik S Thomsen, Prof.

    University Hospital at Herlev Copenhagen Denmark

    STUDY CHAIR

Central Study Contacts

Yousef W. Nielsen, MD

CONTACT

+45 44884391yujwni01@heh.regionh.dk

jakob M Møller, M.Sc.

CONTACT

+ +45 44883996jaml@heh.regionh.dk

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2007

First Posted

October 2, 2007

Study Start

September 1, 2007

Study Completion

January 1, 2010

Last Updated

February 3, 2009

Record last verified: 2009-02

Locations

DK(1)