exertional leg pain peripheral arterial disease
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: patients: - ongoing reversible exertional pain in the lower right and/or left leg (Fontaine 2b) - ongoing rest pain in the lower right and/or left leg (Fontaine 3) (if possible) - age 40 years or older;healthy volunteers: - no history of cardiovascular disease - no cardiovascular risk factors
Exclusion criteria
Exclusion criteria: for all groups: - history of muscular diseases - diabetes mellitus - metabolic diseases - (locomotor) neurologic abnormalities or diseases - known systemic disorders - standard contraindications for MRI;healthy controls: use of any cardiovascular medication, including but not limited to lipid-lowering therapy, antihypertensive drugs, antidiabetic drugs, platelet aggregation inhibitors and anticoagulants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 31P MRS: - PCr recovery rate after exercise or induced ischemia - time to lowest PCr concentration after exercise or induced ischemia BOLD-MRI: - signal intensity (SI) after exercise or induced ischemia - time to peak (TTP) after exercise or induced ischemia 1H MRS: - decay or loss of deoxymyoglobine signal after exercise or induced ischemia intraclass coefficient (ICC) for all the abovementioned parameters. | — |
Secondary
| Measure | Time frame |
|---|---|
| - to demonstrate a correlation between 31P MRS and BOLD-MRI and/or 1H MRS - to demonstrate a correlation between 31P MRS and clinical symptoms - to demonstrate a correlation between BOLD-MRI or 1H MRS and clinical symptoms - to derive a dynamic pH-curve from the inorganic phosphate peak detected by dynamic 31P MRS and correlate these changes with clinical symptoms (pain) | — |
Countries
Netherlands