跳至主要内容
临床试验/NCT03723473
NCT03723473招募中不适用

Peripheral Artery Disease: Gated P-31 Magnetic Resonance Spectroscopy in Functional Assessment of Peripheral Artery Disease (spectroAMI)

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Muscle phosphocreatine (PCr) recovery time constant

研究概览

简要总结

To explore the reliability of P-31 MR spectroscopy mitochondrial function in patients with peripheral arterial occlusive disease.

详细描述

Peripheral arterial occlusive disease (PAOD) is defined as the partial or total obstruction of one or more lower extremity arteries, most often of atherosclerotic origin. It is a common disease whose 5-years mortality is near 30%.The positive diagnosis is based on clinical examination and measurement of the ankle-brachial index (ABI), which is the ratio of systolic pressure of ankle and brachial systolic pressure. The threshold value for the diagnosis is <0.90. Physiopathologically, mitochondria have the predominant role of providing the ATP necessary for the energetic needs of myocytes, which increase drastically during muscle contraction during exercise. This energy production is of course conditioned by the availability of oxygen. In patients with PAOD, the decrease in blood flow secondary to significant stenosis has the direct consequence of disrupting oxygen delivery to distal muscles and thus limiting muscular performance. Because mitochondrial respiration is the only metabolic pathway capable of providing the energy needed to sustain an effort of several minutes, intermittent claudication in PAOD has logically been related to a hemodynamic mechanism of intermittent muscle hypoperfusion. Recently, an increasing number of histological or functional studies have suggested that episodes of ischemia-reperfusion could induce mitochondrial dysfunction. Medical treatment of patients frequently includes statins while a direct deleterious effect on mitochondrial function has been suspected, inducing a deterioration of the muscular oxidative capacity which would increase the factors hemodynamics and may accumulate in mitochondrial myopathy. In the light of these elements, it is clear that there would be a benefit in being able to distinguish and quantify 1) the part of the reduction of mitochondrial activity secondary to the hemodynamic factor alone due to a decreased muscle perfusion 2) the mitochondrial involvement (mitochondriopathy) potentially induced by oxidative stress in PAOD. 2 sub-groups are distinguished to identify the statin-induced mitochondrial dysfunction.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Peripheral arterial occlusive disease (PAOD) with claudication and surgery planning with proximal lesion (iliac or femoral (x-ray angiography or CT or MRA) and no distal lesions (doppler)
  • ABI<0.90 or >1.30
  • signed consent form
  • health insurance coverage

排除标准

  • Contraindication in the practice of MRI: pacemaker, metallic cardiac valve, intra-ocular metal part, claustrophobia
  • critical ischemia >15 days
  • Type 1 or 2 diabetes
  • weight >200kg
  • non stabilized hypertension
  • beta-blockers
  • non-atherosclerotic vascular occlusive disease (Buerger disease, Takayasu disease, venous disease, trapped popliteal artery etc..)
  • Neurological pathology/non-voluntary contraction

结局指标

主要结局

Muscle phosphocreatine (PCr) recovery time constant

时间窗: During the MRI procedure

Muscle phosphocreatine (PCr) recovery time constant (index of muscle aerobic capacity) after gated low-intensity exercise (2"maximum voluntary isometric dorsiflexion contractions, at 30s intervals for 8min (total contractions = 15)

次要结局

  • PCr recovery time constant(During the MRI procedure)
  • Muscular volume and content(During the MRI procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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