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novel noninvasive molecular imaging modalities for ischemia in peripheral arterial disease

novel noninvasive molecular imaging modalities for ischemia in peripheral arterial disease - MR modalities for PAD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON42178
Enrollment
50
Registered
2015-03-17
Start date
2015-01-31
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

exertional leg pain peripheral arterial disease

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)