Clinical Trial: Contrast Enhanced Ultrasound and Muscle

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Echographie de Contraste Pour l'Analyse de la Perfusion Musculaire Dans l'ischémie Critique

Brief Summary: 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.

Detailed Summary:

• 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
  Sponsor: University Hospital, Grenoble
  

  Current Primary Outcome: Time to Peak [ Time Frame: M0 (before revascularisation) and M1 (One month after the revascularisation). ]

  Time to peak modification, before and one month after the revascularization
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:

  • Curves datas [ Time Frame: M0 (before revascularisation) M1 (one month after revascularisation). ]
    Evaluation of other data issued from the kinetic curve of enhancement (time between injection and peak, area under curve, quantitative value of peak, time of vein-muscle transit (TTP muscle -TTP vein) before and after revascularization.
  • kinetics values [ Time Frame: M0 (before revascularisation) and M1 (one month after revascularisation). ]
    Study of correlation between kinetic data (TTP) and measures of TcPO2 and toe systolic pressure before revascularization and one month after revascularization
  • Time to peak [ Time Frame: M0, M1 and M3 (three month after revascularisation) ]
    Study of predictive value of TTP before revascularization on success of revascularization at 1 month (clinical evaluation on pain, lack of minor or major amputation, healing of ulcer) and at 3 months (survival, lack of minor or major amputation, new surgery).
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: University Hospital, Grenoble
  

  Dates:
  Date Received: April 29, 2014
  Date Started: February 2011
  Date Completion:
  Last Updated: March 4, 2016
  Last Verified: April 2014