eg Muscle Metabolism Assessment in Critical Limb Ischemia with 7 Tesla MRI

Completed

• Conditions: Critical limb ischemia / Peripheral arterial occlusive disease; 10003216

• Registration Number: NL-OMON36666
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- Age > 18 years;
- Severe infra-popliteal PAOD (Fontaine class III and / or IV); Fontaine III: persistent, recurring rest pain requiring analgesia; Fontaine IV: non-healing ulcers present for > 4 weeks without evidence of improvement in response to conventional therapies
- Ankle brachial index < 0.6 or unreliable (non-compressible or not in proportion to the Fontaine classification);
- Written informed consent. ;The criteria apply to patients. Healthy controls may be included if they are above 18 years and have no signs of PAOD.

Exclusion Criteria

-Pregnancy
-Ineligible for scanning in the 7T MRI: subjects with cardiac pacemakers, claustrophobia, or metallic objects, i.e. stents, surgical clips etc. and all patients with bio-implants not explicitly indicated as safe to 7T MRI (see: mrisafety.com).;The abovementioned criteria apply to both patients and healthy controls.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Ad 1: Fifteen healthy controls will be subjected to a short period of<br /><br>unilateral arterial occlusion of the leg by supersystolic compression of the<br /><br>lower extremity arteries with an inflatable cuff. 7T 31P MRS will be performed<br /><br>before, during and after occlusion. Pi/ATP and PCr/ATP-ratios and pH will be<br /><br>compared between timepoints.<br /><br>The fifteen healthy controls will be scanned on a separate occasion and results<br /><br>will be compared to test the test-retest reliability of the method.<br /><br>Ad 2: Fifteen patients with proven chronic infra-popliteal CLI, who are not<br /><br>candidates for surgical or radiological revascularization will undergo 7T 31P<br /><br>MRS without applying arterial compression. Pi/ATP and PCr/ATP-ratios and pH<br /><br>will be determined and compared to healthy controls with and without ischemia.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>