Spectroscopy in Functional Assessment of Peripheral Artery Disease (spectroAMI)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-13

Study Completion Date

2025-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Arterial Occlusive Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PAOD patients statin (+)

Patients with Peripheral Arterial Occlusive Disease (PAOD) and statin treatment.

They will have Magnetic Resonance Imaging (MRI; muscular volume and composition) and gated-P-31 magnetic resonance spectroscopy (MRS) with low-intensity ergometric exercise. It will be performed before surgery (within 48h) and after surgery (first week)

Magnetic Resonance Imaging (MRI)

Intervention Type DEVICE

MRI (muscular volume and composition) and gated-P-31 magnetic resonance spectroscopy (MRS) with low-intensity ergometric exercise.

PAOD patients statin (-)

Patients with Peripheral Arterial Occlusive Disease (PAOD) without statin treatment .

They will have Magnetic Resonance Imaging (MRI ; muscular volume and composition) and gated-P-31 magnetic resonance spectroscopy (MRS) with low-intensity ergometric exercise. It will be performed before surgery (within 48h) and after surgery (first week)

Magnetic Resonance Imaging (MRI)

Intervention Type DEVICE

MRI (muscular volume and composition) and gated-P-31 magnetic resonance spectroscopy (MRS) with low-intensity ergometric exercise.

Interventions

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Magnetic Resonance Imaging (MRI)

MRI (muscular volume and composition) and gated-P-31 magnetic resonance spectroscopy (MRS) with low-intensity ergometric exercise.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No