Ischemia Clinical Trial
Official title:
Echographie de Contraste Pour l'Analyse de la Perfusion Musculaire Dans l'ischémie Critique
The primary objective of our work is to show that quantification of muscular microvascularisation evaluated by injection of contrast agent is different between chronic critical limb ischemia (before revascularization) and after (healing of ischemia) and thus make the proof of its utility in evaluation of PAD therapeutics.
- Peripheral arterial disease (PAD) is a frequent disease the incidence of which in men
is about 32.5°/°° before 40 years and 71°/°° after 50 years. Prevalence of the disease
increases with age to reach 3.7% of 60 to 69 year old subjects (Kannel 1970, 1985,
Bloch 1985).
- Critical limb ischemia (CLI) ischemia is defined by typical chronic ischemic rest pain
or ischemic skin lesions either ulcers or gangrene for more than two weeks (Norgren).
Incidence is about 500 - 1000 / 106 / year in Europe and United states. Critical limb
ischemia concerns 15 - 20% of patients with intermittent claudication (Eneroth 1992,
Taylor 1989). Development can lead to limb loss with a frequency estimated between 7%
at 5 years to 12% at 10 years. Problem is crucial for patients who cannot benefit from
revascularization. Results of single medical treatments are uncertain. Development of
neovascularisation by innovating therapeutic (autolog cell stem grafts, intramuscular
growth factor injections ) represent an exciting and promising field of research.
- Peripheral arterial disease evaluation and staging are based on measures of resting
ankle pressures, diagnosis of stenosis and obliteration (duplex, angiography, computed
tomography scan and magnetic resonance imaging) and on measure of microcirculatory skin
perfusion by Tc PO2. On the other hand, there is no simple tool to measure muscular
microvascularisation whereas muscles suffer from ischemia in the same way as skin and
nerves. Measures of muscular perfusion can be performed by Tc 99, magnetic resonance
imaging but this is not used in clinical practice. CEUS used in routine to assess
hepatic microvascularisation has recently been shown to be potentially useful to study
muscle (Kramer 2008, Weber 2007).
- Ultrasonic contrast agents are intravascular microbubbles which used at low mechanical
index generate harmonics and allow real time imaging in ultrasonography. Their use
allows study of parenchyma enhancement in real time, notably of liver and kidneys; they
are also used in practice to differentiate benign and malign tumors (Correas 2009).
Correlations have been shown between muscle enhancement studied by CEUS and histologic
data of capillary vascularisation (Weber 2005). More recently some authors have shown
that CEUS may allow to differentiate patients with PAD at a stage of intermittent
claudication and patients without PAD (Duerschmied 2006).Very few studies have studied
patients with CLI. Duerschmied and all have shown that kinetic data of muscle
enhancement may reflect collateral circulation developed in reaction to chronic
ischemia. CEUS may be used to study muscular perfusion in the same way as TcPO2
reflects cutaneous vascularisation and may become an evaluation criteria of PAD
therapeutics in a near future.
- We propose to study muscular perfusion by CEUS in patients with critical limb ischemia
eligible to revascularization (PTA or bypass) before and after revascularization.
Microbubbles injection leads to an increase in muscle echogenicity in two sequences: a
rapid phase 15-20 s after injection (arteriolar filling) then a more intense second
phase (veinular and capillary filling) (Duerschmied 2006). These two phases may be
described by measures of acoustic intensity function of time and in particular time to
peak (TTP), area under the curve (AUC). Time to peak seems to be the more reliable
criteria (Duerschmied).
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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