Magnetic resonance Imaging techniques in patients with Refractory Critical Limb ischemia
Completed
- Conditions
- CLIPAD10003216
- Registration Number
- NL-OMON44605
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
Informed consent
Age >= 16 years
Ability to lie still for 15 minutes without rest pain.
Exclusion Criteria
Acute limb ischemia
Earlier bypass surgery at the side of imaging
Any intravascular stent in the femoral artery at the side of imaging
MR related exclusion criteria
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoints are:<br /><br>• Signal-to-noise ratio (SNR) for each MRI technique. SNR of the MRI image and<br /><br>the SNR of the derived perfusion graphs.<br /><br>• Inter observer calculations of the two MRI techniques. Intraclass correlation<br /><br>coefficient (ICC) is calculated for two observers both independently<br /><br>delineating regions of interests for calculation of perfusion graphs.<br /><br>• Discriminative value - calculation of correlation values of measurement and<br /><br>image parameters with the three study groups (Spearman correlation).</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the level of discomfort of the different techniques in patients with<br /><br>and without critical ischemia.</p><br>