Spectroscopy in Functional Assessment of Peripheral Artery Disease (spectroAMI)

Arterial Occlusive Diseases Clinical Trial

— SPECTROAOMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03723473
• Other study ID #: 1708029
• Secondary ID: 2017-A01421-52
• Status: Recruiting
• Start date: February 13, 2019
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Pierre CROISILLE, PhD
• Phone: (0)477127584
• Email: croisille[@]creatis.insa-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease

Intervention

Device:
• Magnetic Resonance Imaging (MRI)
MRI (muscular volume and composition) and gated-P-31 magnetic resonance spectroscopy (MRS) with low-intensity ergometric exercise.

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Dr MAYER Ronald A. Department of Physiology, Michigan State University, Dr SLADE Jill M. Department of Osteopathic Manipulative Medicine, Michigan State University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle phosphocreatine (PCr) recovery time constant	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)	During the MRI procedure
Secondary	Muscular volume and content	impact of muscular volume and content. Measures will be extracted from DIXON and T2* MRI	During the MRI procedure
Secondary	PCr recovery time constant	impact of statin treatment on PCr recovery time constant	During the MRI procedure