Spectroscopy in Functional Assessment of Peripheral Artery Disease (spectroAMI)

NCT03723473 | Recruiting

• 2 other identifiers: 17080292017-A01421-52
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arterial Occlusive Diseases

Keywords

Peripheral Arterial Occlusive Disease (PAOD); Phosphorus-31; Magnetic Resonance Imaging (MRI); Spectroscopy; Revascularization; Claudication with surgical planning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Muscular volume and content

  During the MRI procedure

• PCr recovery time constant

  During the MRI procedure

Study Arms (2)

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)

Device: Magnetic Resonance Imaging (MRI)

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)

Device: Magnetic Resonance Imaging (MRI)

Interventions

Magnetic Resonance Imaging (MRI) DEVICE

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

PAOD patients statin (+); PAOD patients statin (-)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with Peripheral arterial occlusive disease with claudication and surgery planning

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Dr MAYER Ronald A. Department of Physiology, Michigan State University: collaborator
• Dr SLADE Jill M. Department of Osteopathic Manipulative Medicine, Michigan State University: collaborator

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

RECRUITING

MeSH Terms

Conditions

Arterial Occlusive Diseases; Peripheral Arterial Occlusive Disease 1

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Pierre CROISILLE, PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre CROISILLE, PhD

CONTACT

(0)477127584; croisille@creatis.insa-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 29, 2018
• Study Start: February 13, 2019
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)