Critical Limb Ischemia: MRA And CTA Study (Feasibility)

Withdrawn

Conditions: critical limb ischemia
severe peripheral vascular disease
10003216

Registration Number: NL-OMON37452

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

Critical limb ischemia > 2 weeks
ankle-brachial pressure index < 0.7, or toe pressure < 50 mmHg
Referred for digital subtraction angiography
Normal renal function, defined as eGFR > 60 ml/min
Written informed consent

Exclusion Criteria

Inability to give informed consent
Contraindications for MRI, i.e. metal implants or claustrophobia
Contraindications for CTA, i.e. allergic reactions to iodinated contrast agents, hyperthyroidism, goiter or pregnancy
Patient participates in another study

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the burden for the patient of CTA and MRA expressed<br /><br>as the score of the visual analogue scale (VAS) and on a 5-point Likert scale. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The diagnostic accuracy of CTA and MRA to identify arterial stenoses > 50% and<br /><br>occlusions in patients with CLI will be compared to DSA as the reference<br /><br>standard.<br /><br>Interobserver agreement for grading arterial stenosis and occlusions with CTA<br /><br>and MRA in patients with CLI will be expressed as weighted *-values.<br /><br>The correlation between arterial calcifications and the diagnostic accuracy of<br /><br>CTA and MRA to identify arterial stenosis and occlusion in patients with CLI<br /><br>will be evaluated. </p><br>