NCT00834548

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 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

Study Start

First participant enrolled

June 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2008

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
Last Updated

February 3, 2009

Status Verified

February 1, 2009

First QC Date

August 26, 2008

Last Update Submit

February 1, 2009

Conditions

AtherosclerosisIntermittent Claudication

Keywords

Magnetic resonancewhole bodyangiographyhybrid protocolMRI

Outcome Measures

Primary Outcomes (1)

  • Diagnostic quality of WB-MRA

Secondary Outcomes (2)

  • Signal to noise ratio

  • Contrast to noise ratio

Study Arms (2)

1

WB-MRA standard protocol

Procedure: Whole body magnetic resonance angiography (WB-MRA)

2

WB-MRA hybrid protocol

Procedure: Whole body magnetic resonance angiography (WB-MRA)

Interventions

Whole body magnetic resonance angiography (WB-MRA)PROCEDURE

WB-MRA will be performed once in each patient.

12

Eligibility Criteria

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

Copenhagen University Hospital Herlev

Herlev Copenhagen, 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

  • Yousef W Nielsen, MD

    Copenhagen University Hospital at Herlev

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 26, 2008

First Posted

February 3, 2009

Study Start

June 1, 2008

Study Completion

August 1, 2008

Last Updated

February 3, 2009

Record last verified: 2009-02

Locations

DK(1)