se of [15O] H2O PET to determine lower extremity muscle perfusion in patients with peripheral artery disease

Conditions: Peripheral artery disease
artierial insufficiency
atherosclerosis
10003184
10003216

Registration Number: NL-OMON53834

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

18 years or older; written informed consent and; chronic limb threatening
ischemia (Rurtherford 4-6) at the leg that will be revascularized

Exclusion Criteria

Insufficient knowledge of the Dutch language, illiteracy, language barrier or
not compos mentis; lower leg fractures within the past 12 months; (partial)
amputation of one of the feet and/or legs; Rutherford 4-6 at the contralateral
leg; pregnant or breast feeding; severe peripheral oedema; taller than 1,90 m
(because of the limited field of view of the PET scanner; the PET camera only
measures 1.06m and we want to picture the entire legs); not able to lay supine
for 6 minutes; acute ischemia and; severe claustrophobia.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint of this study is to correlate regional muscle tissue<br /><br>perfusion measured with [15O] H2O PET to local skin tissue perfusion measured<br /><br>with TcPO2. We will have measurements of both legs of 15 patients, who will<br /><br>undergo a [15O] H2O PET scan and local skin perfusion measurements at 4<br /><br>locations twice (before and after the intervention). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A secundary parameter is is to correlate pre-intervention tissue perfusion<br /><br>(measured with [15O] H2O PET and TcPO2) with post-intervention tissue<br /><br>perfusion. We will also correlate these parameters with arterial blood pressure<br /><br>(ABI and TBP).<br /><br><br /><br>Antoher secudnarry parameter is the inter- and intra-rater variability between<br /><br>two researchers who perform measurements on the [15O] H2O PET-scans.</p><br>