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

Leg Muscle Metabolism Assessment in Critical Limb Ischemia with 7 Tesla MRI - CLI and 7T 31P MRS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36666

Enrollment

Registered

2011-01-21

Start date

2011-05-17

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

Critical limb ischemia / Peripheral arterial occlusive disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results