Patient Acceptance of Whole Body Magnetic Resonance Angio... | NCT00556101

Studies
Patient Acceptance of Whole Body Magnetic Resonance Angiography

NCT00556101

Sponsor

Copenhagen University Hospital at Herlev

Status

Completed

Last Update Posted

Aug 19, 2009Estimated

Enrollment

81Estimated

Phase

Not provided

Conditions

Atherosclerosis
Intermittent Claudication
MRI

Interventions

Whole body magnetic resonance angiography

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

Aug 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

Nov 2007

Primary Completion Date

Not provided

Completion Date

Jul 2009Actual

First Submitted Date

Nov 8, 2007

First Submission Date that Met QC Criteria

Nov 8, 2007

First Posted Date

Nov 9, 2007Estimated

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

Aug 18, 2009

Last Update Posted Date

Aug 19, 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

Investigation of how the patients experience whole body MRA. After the WB-MRA the patients will fill in a questionnaire, that contains questions about the WB-MRA procedure and how the patient felt during the examination.

We expect that the patients will report a high degree of satisfaction with the WB-MRA procedure, with little discomfort.

Detailed Description

WB-MRA is performed in patients referred for conventional x-ray based angiography. The WB-MRA is performed first in all patients.

After both examinations are completed the patients will be asked to fill in a questionnaire containing questions about their experience of the 2 procedures.

We will then compare the results for the procedures.

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

81Estimated

Name	Type	Description	Arm Group Labels	Other Names
Whole body magnetic resonance angiography	Procedure

Measure	Description	Time Frame
Patient acceptance of Whole body 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 pheripheral arterial disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henrik S Thomsen, Prof. MD.	University Hospital at Herlev Copenhagen Denmark	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Radiology, Herlev University Hospital		Herlev Copenhagen	Herlev	DK2730	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