ovel noninvasive molecular imaging modalities for ischemia in peripheral arterial disease

Completed

Conditions: exertional leg pain
peripheral arterial disease
10028302
10003216

Registration Number: NL-OMON42178

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>31P MRS:<br /><br>- PCr recovery rate after exercise or induced ischemia<br /><br>- time to lowest PCr concentration after exercise or induced ischemia<br /><br><br /><br>BOLD-MRI:<br /><br>- signal intensity (SI) after exercise or induced ischemia<br /><br>- time to peak (TTP) after exercise or induced ischemia<br /><br><br /><br>1H MRS:<br /><br>- decay or loss of deoxymyoglobine signal after exercise or induced ischemia<br /><br><br /><br>intraclass coefficient (ICC) for all the abovementioned parameters.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- to demonstrate a correlation between 31P MRS and BOLD-MRI and/or 1H MRS<br /><br>- to demonstrate a correlation between 31P MRS and clinical symptoms<br /><br>- to demonstrate a correlation between BOLD-MRI or 1H MRS and clinical symptoms<br /><br>- to derive a dynamic pH-curve from the inorganic phosphate peak detected by<br /><br>dynamic 31P MRS and correlate these changes with clinical symptoms (pain)</p><br>