Assessing mitochondrial function in patients with peripheral artery disease
Peripheral Artery Disease: Gated P-31 Magnetic Resonance Spectroscopy in Functional Assessment of Peripheral Artery Disease (spectroAMI)
This study is testing a special imaging technique to see how well the muscles in people with peripheral artery disease are working during exercise and how oxygen delivery affects their performance.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 1 site (Saint-Étienne) |
| Trial ID | NCT03723473 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the reliability of phosphorus-31 magnetic resonance spectroscopy in assessing mitochondrial function in patients diagnosed with peripheral arterial occlusive disease (PAOD). The study focuses on patients who experience claudication and are scheduled for surgical intervention due to significant arterial lesions. By measuring mitochondrial respiration, the study seeks to understand how oxygen delivery disruptions affect muscle performance during exercise in these patients. The findings could provide insights into the underlying mechanisms of PAOD and guide treatment strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with peripheral arterial occlusive disease experiencing claudication and scheduled for surgery due to proximal arterial lesions.
Not a fit: Patients with critical ischemia, diabetes, or other specific vascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of mitochondrial dysfunction in PAOD, potentially leading to improved treatment options for patients.
How similar studies have performed: While the approach of using phosphorus-31 MR spectroscopy is relatively novel, similar studies have indicated potential for success in understanding mitochondrial function in other conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Saint-Étienne
- Chu Saint-Etienne — Saint-Étienne, France (Recruiting)
Study contacts
- Principal investigator: Pierre CROISILLE, PhD — Chu Saint-Etienne
- Study coordinator: Pierre CROISILLE, PhD
- Email: croisille@creatis.insa-lyon.fr
- Phone: (0)477127584
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.