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

Use of [15O] H2O PET to determine lower extremity muscle perfusion in patients with peripheral artery disease - PEPPER trial

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53834
Enrollment
15
Registered
2023-06-21
Start date
2023-08-28
Completion date
Unknown
Last updated
2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral artery disease

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)