Whole-Body MRA at 3T - A Comparison Between Two Different... | NCT00834548

Studies
Whole-Body MRA at 3T - A Comparison Between Two Different Scan Protocols

NCT00834548

Sponsor

Copenhagen University Hospital at Herlev

Status

Completed

Last Update Posted

Feb 3, 2009Estimated

Enrollment

26Estimated

Phase

Not provided

Conditions

Atherosclerosis
Intermittent Claudication

Interventions

Whole body magnetic resonance angiography (WB-MRA)

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Not provided

Completion Date

Aug 2008Actual

First Submitted Date

Aug 26, 2008

First Submission Date that Met QC Criteria

Feb 1, 2009

First Posted Date

Feb 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2009

Last Update Posted Date

Feb 3, 2009Estimated

Name	Class
Rigshospitalet, Denmark	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Patients suffering peripheral arterial disease must undergo imaging procedures before endovascular or surgical procedures.

WB-MRA is an imaging procedure that can visualise the arterial system. WB-MRA can be performed in different manners. On option is to start the scan in the head region and continue down the body to the feet (standard protocol). Another option is to use a hybrid protocol that first examines the head and lower leg followed by examination of the pelvic and upper leg region.

A comparison between the standard and hybrid protocols has not been performed in a 3T high magnetic field system, therefore we will perform such a study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Whole body magnetic resonance angiography (WB-MRA)	Procedure	WB-MRA will be performed once in each patient.	1 2

Measure	Description	Time Frame
Diagnostic quality of WB-MRA

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with peripheral arterial disease

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yousef W Nielsen, MD	Copenhagen University Hospital at Herlev	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Copenhagen University Hospital Herlev		Herlev Copenhagen		DK 2730	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D050197	Atherosclerosis
D007383	Intermittent Claudication

Ancestor Terms

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Signal to noise ratio
Contrast to noise ratio