Clinical trial NCT03723473: Spectroscopy in Functional Assessment of Peripheral Artery Disease (spectroAMI)
Official title: Peripheral Artery Disease: Gated P-31 Magnetic Resonance Spectroscopy in Functional Assessment of Peripheral Artery Disease (spectroAMI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arterial Occlusive Diseases
Keywords: Peripheral Arterial Occlusive Disease (PAOD)
Phosphorus-31
Magnetic Resonance Imaging (MRI)
Spectroscopy
Revascularization
Claudication with surgical planning
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Dr MAYER Ronald A. Department of Physiology, Michigan State University
name: Dr SLADE Jill M. Department of Osteopathic Manipulative Medicine, Michigan State University
First posted: 2018-10-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Peripheral arterial occlusive disease with claudication and surgery planning

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Muscle phosphocreatine (PCr) recovery time constant
timeFrame: During the MRI procedure
Secondary outcomes:
measure: Muscular volume and content
timeFrame: During the MRI procedure
measure: PCr recovery time constant
timeFrame: During the MRI procedure
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Pierre CROISILLE, PhD
role: PRINCIPAL_INVESTIGATOR
References: