NCT00560534

Brief Summary

To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using subsystolic venous compression of the thigh.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 16, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 19, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

August 19, 2009

Status Verified

August 1, 2009

First QC Date

November 16, 2007

Last Update Submit

August 18, 2009

Conditions

AtherosclerosisIntermittent Claudication

Keywords

Magnetic resonancewhole bodyangiographyvenous compressionMRI

Outcome Measures

Primary Outcomes (1)

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

    1 month

Interventions

Whole body magnetic resonance angiographyPROCEDURE

Magnetic resonance angiography using a paramagnetic contrast agent.Venous compression performed with a blood-pressure cuff around both thighs.

Eligibility Criteria

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

Patients with peripheral 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, DK-2730, 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
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 19, 2007

Study Start

June 1, 2008

Study Completion

March 1, 2009

Last Updated

August 19, 2009

Record last verified: 2009-08

Locations

DK(1)