The Diagnostic Accuracy of Subtractionless multi-point Dixon Peripheral MR Angiography The DOGMA TRIA

Withdrawn

Conditions: atherosclerosis
peripheral arterial disease
10003216

Registration Number: NL-OMON41042

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

- 18 years or older
- Suspected presence of peripheral arterial disease based on duplex ultrasonography,
magnetic resonance angiography or CT angiography requiring percutaneous intervention
- willing and able to give informed consent

Exclusion Criteria

- Presence of metal implants incompatible with safe MR imaging as determined from the
recent copy of the *MR safety manual* by Shellock et al.
- claustrophobia
- presence of metal fragments in the orbit or eye
- severe renal impairment (GFR<30 mL/min/m2)
- contrast-allergy for gadolinium chelates

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the diagnostic accuracy (sensitivity, specificity, NPV and PPV)<br /><br>for the detection and the severity (%) of peripheral vascular tree stenosis<br /><br>with subtractionless first-pass single contrast medium dose peripheral MR<br /><br>angiography using two-point mDixon fat suppression compared to IA-DSA in<br /><br>patients with peripheral arterial disease referred for percutaneous<br /><br>intervention. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To compare the diagnostic accuracy of subtractionless first-pass single<br /><br>mDixon MRA with conventional subtraction MRA compared to the reference standard<br /><br>DSA in patients with peripheral arterial disease referred for percutaneous<br /><br>intervention in participating centers performing subtraction MRA in their<br /><br>clinical routine workup.<br /><br><br /><br>2. Does mDixon MRA lead to similar treatment decisions as IA-DSA determined by<br /><br>an expert consensus panel consisting of experienced cardiovascular radiologists<br /><br>and vascular surgeons<br /><br><br /><br>3. To compare the diagnostic accuracy of mDixon MRA on a station by station<br /><br>level (i.e. at the aorto-iliac, upper leg and lower leg levels).<br /><br></p><br>